Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-27 @ 4:17 AM
Study NCT ID:
NCT03220204
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Researching Emotions And Cardiac Health: Phase III
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ccelano@partners.org', 'phone': '617-726-6485', 'title': 'Dr. Christopher Celano', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Unexpected Shortness of Breath and Weight Gain', 'notes': 'Participant reported worsening shortness of breath and weight gain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unexpected Chest Pain', 'notes': '3 participants each reported experiencing chest pain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unexpected Shortness of Breath', 'notes': 'Participant reported experiencing shortness of breath.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Participant went to the ED for a urinary tract infection but was not admitted.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unexpected Arm Pain', 'notes': 'Participant reported experiencing arm pain and thought it was likely attributable to weight lifting exercises.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured foot and ankle', 'notes': 'Participant was in a car accident which left them with a fractured foot and ankle.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unexpected Fall', 'notes': 'Participant reported that they had tripped and fell in their home, but that there was no head trauma or need for medical care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Flu and pneumonia', 'notes': 'Participant was hospitalized as a result of having the flu and pneumonia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental state', 'notes': 'Participant was admitted to the hospital as a result of having an altered mental state.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Participant was admitted to the hospital after being found to have a urinary tract infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the PP-based Health Behavior Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and 12 weeks', 'description': 'Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.', 'unitOfMeasure': 'sessions completed out of 12 sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}], 'classes': [{'title': 'Ease', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Utility', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.', 'unitOfMeasure': 'rating out of 10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immediate Impact of the Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}], 'classes': [{'title': 'Optimism', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Positive Affect', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 12 weeks', 'description': 'Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PANAS Scores (Primary Psychological Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMotivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.38', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '8.26', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '5.60', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '7.29', 'groupId': 'OG001'}, {'value': '3.75', 'spread': '7.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in LOT-R Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.43', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '3.05', 'groupId': 'OG001'}, {'value': '2.93', 'spread': '5.92', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '4.66', 'groupId': 'OG001'}, {'value': '2.83', 'spread': '6.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in SOM Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '4.63', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '3.97', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '4.61', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '5.74', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '5.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in HADS-Anxiety Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.79', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-2.07', 'spread': '3.85', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.21', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '3.47', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '4.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in HADS-Depression Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '2.63', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '5.12', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '3.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in KCCQ Scores (Primary Functional Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks HRQoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.74', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '23.28', 'groupId': 'OG001'}, {'value': '10.12', 'spread': '13.94', 'groupId': 'OG002'}]}]}, {'title': '12 weeks Total Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.31', 'spread': '21.39', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '16.65', 'groupId': 'OG002'}]}]}, {'title': '24 weeks HRQoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '22.13', 'groupId': 'OG000'}, {'value': '7.05', 'spread': '26.75', 'groupId': 'OG001'}, {'value': '10.42', 'spread': '12.87', 'groupId': 'OG002'}]}]}, {'title': '24 weeks Total Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '18.49', 'groupId': 'OG000'}, {'value': '-5.37', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '16.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in SF-12 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks Mental Health Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.03', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '8.39', 'groupId': 'OG001'}, {'value': '5.19', 'spread': '5.73', 'groupId': 'OG002'}]}]}, {'title': '12 weeks Physical Health Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '9.22', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '7.18', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '10.61', 'groupId': 'OG002'}]}]}, {'title': '24 weeks Mental Health Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.54', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '11.32', 'groupId': 'OG001'}, {'value': '8.28', 'spread': '8.73', 'groupId': 'OG002'}]}]}, {'title': '24 weeks Physical Health Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '8.27', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '11.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in MOS SAS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '2.38', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '3.56', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '1.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in Sodium Intake (as Measured With the SSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.25', 'spread': '17.62', 'groupId': 'OG000'}, {'value': '-12.93', 'spread': '15.90', 'groupId': 'OG001'}, {'value': '-11.68', 'spread': '19.77', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.18', 'spread': '20.14', 'groupId': 'OG000'}, {'value': '-14.65', 'spread': '20.26', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '23.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily." It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher sodium intake.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in Self-Reported Medication Adherence (SRMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '43', 'spread': '51', 'groupId': 'OG000'}, {'value': '0', 'spread': '39', 'groupId': 'OG001'}, {'value': '21', 'spread': '70', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '36', 'spread': '50', 'groupId': 'OG000'}, {'value': '8', 'spread': '64', 'groupId': 'OG001'}, {'value': '8', 'spread': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '454', 'spread': '1066', 'groupId': 'OG000'}, {'value': '409', 'spread': '1033', 'groupId': 'OG001'}, {'value': '-412', 'spread': '1305', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '821', 'spread': '2232', 'groupId': 'OG000'}, {'value': '-330', 'spread': '1287', 'groupId': 'OG001'}, {'value': '76', 'spread': '1207', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks.', 'unitOfMeasure': 'steps/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Moderate to Vigorous Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '5.72', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '-4.11', 'spread': '19.02', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '5.18', 'spread': '15.02', 'groupId': 'OG000'}, {'value': '-2.66', 'spread': '4.48', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '6.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks.', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Feasibility of Actigraph', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'OG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point.', 'unitOfMeasure': 'Participants with adequate activity data', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'FG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMotivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'FG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PP-based Health Behavior Intervention', 'description': "Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.\n\nPP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."}, {'id': 'BG001', 'title': 'MI-based Educational Control Condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.\n\nMotivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.'}, {'id': 'BG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '74.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '71.8', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '70.8', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Positive and Negative Affect Schedule (PANAS)', 'classes': [{'categories': [{'measurements': [{'value': '31.53', 'spread': '7.95', 'groupId': 'BG000'}, {'value': '33.93', 'spread': '7.21', 'groupId': 'BG001'}, {'value': '32.33', 'spread': '5.81', 'groupId': 'BG002'}, {'value': '32.60', 'spread': '6.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Life Orientation Test-Revised (LOT-R)', 'classes': [{'categories': [{'measurements': [{'value': '17.33', 'spread': '3.64', 'groupId': 'BG000'}, {'value': '18.13', 'spread': '4.55', 'groupId': 'BG001'}, {'value': '15.73', 'spread': '4.77', 'groupId': 'BG002'}, {'value': '17.07', 'spread': '4.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'State Optimism Measure (SOM)', 'classes': [{'categories': [{'measurements': [{'value': '26.33', 'spread': '4.85', 'groupId': 'BG000'}, {'value': '26.93', 'spread': '5.54', 'groupId': 'BG001'}, {'value': '27.67', 'spread': '4.51', 'groupId': 'BG002'}, {'value': '26.98', 'spread': '4.90', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Higher scores indicate higher levels of state optimism.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression Scale (HADS) anxiety subscale', 'classes': [{'categories': [{'measurements': [{'value': '6.47', 'spread': '3.72', 'groupId': 'BG000'}, {'value': '6.33', 'spread': '4.01', 'groupId': 'BG001'}, {'value': '5.60', 'spread': '4.56', 'groupId': 'BG002'}, {'value': '6.13', 'spread': '4.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression Scale (HADS) depression subscale', 'classes': [{'categories': [{'measurements': [{'value': '5.07', 'spread': '3.35', 'groupId': 'BG000'}, {'value': '5.40', 'spread': '3.92', 'groupId': 'BG001'}, {'value': '5.13', 'spread': '4.02', 'groupId': 'BG002'}, {'value': '5.20', 'spread': '3.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'classes': [{'categories': [{'measurements': [{'value': '75.36', 'spread': '19.16', 'groupId': 'BG000'}, {'value': '68.91', 'spread': '24.35', 'groupId': 'BG001'}, {'value': '78.15', 'spread': '14.99', 'groupId': 'BG002'}, {'value': '74.14', 'spread': '19.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical Outcomes Study Short Form-12 (SF-12)', 'classes': [{'title': 'Physical Health Composite Score', 'categories': [{'measurements': [{'value': '42.13', 'spread': '10.05', 'groupId': 'BG000'}, {'value': '37.94', 'spread': '13.68', 'groupId': 'BG001'}, {'value': '40.14', 'spread': '10.40', 'groupId': 'BG002'}, {'value': '40.07', 'spread': '11.36', 'groupId': 'BG003'}]}]}, {'title': 'Mental Health Composite Score', 'categories': [{'measurements': [{'value': '42.21', 'spread': '11.20', 'groupId': 'BG000'}, {'value': '50.26', 'spread': '8.72', 'groupId': 'BG001'}, {'value': '48.22', 'spread': '9.99', 'groupId': 'BG002'}, {'value': '46.90', 'spread': '10.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Higher scores indicate higher level of health related QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical Outcomes Study Specific Adherence Scale (MOS SAS)', 'classes': [{'categories': [{'measurements': [{'value': '11.87', 'spread': '2.33', 'groupId': 'BG000'}, {'value': '12.60', 'spread': '2.10', 'groupId': 'BG001'}, {'value': '12.73', 'spread': '1.28', 'groupId': 'BG002'}, {'value': '12.40', 'spread': '1.95', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Higher scores indicate better adherence to health behaviors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scored Sodium Questionnaire (SSQ)', 'classes': [{'categories': [{'measurements': [{'value': '71.10', 'spread': '29.09', 'groupId': 'BG000'}, {'value': '64.90', 'spread': '27.79', 'groupId': 'BG001'}, {'value': '64.37', 'spread': '21.15', 'groupId': 'BG002'}, {'value': '66.79', 'spread': '25.82', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily." It is used to calculate daily sodium intake (Range: 0-215). Higher scores indicate higher sodium intake.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-Reported Medication Adherence (SRMA)', 'classes': [{'categories': [{'measurements': [{'value': '95.33', 'spread': '5.16', 'groupId': 'BG000'}, {'value': '96.67', 'spread': '4.88', 'groupId': 'BG001'}, {'value': '96.67', 'spread': '6.17', 'groupId': 'BG002'}, {'value': '96.22', 'spread': '5.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-100).', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '3465', 'spread': '1484', 'groupId': 'BG000'}, {'value': '3458', 'spread': '1616', 'groupId': 'BG001'}, {'value': '4195', 'spread': '2375', 'groupId': 'BG002'}, {'value': '3706', 'spread': '1857', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome).', 'unitOfMeasure': 'steps/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Moderate to Vigorous Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '15.2', 'spread': '19.8', 'groupId': 'BG002'}, {'value': '9.5', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Feasibility of Actigraph', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'While 50 participants enrolled in this study, only 45 participants were randomized to a condition as 2 participants withdrew consent, 1 participant terminated consent, 1 participant was lost to follow-up, and 1 participant did not provide the data necessary to be randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-02', 'size': 439200, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-19T11:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, single-blinded, controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2017-07-14', 'resultsFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-20', 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the PP-based Health Behavior Intervention', 'timeFrame': 'Change between baseline and 12 weeks', 'description': 'Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the Exercises', 'timeFrame': '12 weeks', 'description': 'Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.'}, {'measure': 'Immediate Impact of the Exercises', 'timeFrame': 'Weekly, up to 12 weeks', 'description': 'Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.'}, {'measure': 'Change in PANAS Scores (Primary Psychological Outcome)', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.'}, {'measure': 'Changes in LOT-R Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism.'}, {'measure': 'Changes in SOM Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism.'}, {'measure': 'Changes in HADS-Anxiety Subscale Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.'}, {'measure': 'Change in HADS-Depression Subscale Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.'}, {'measure': 'Changes in KCCQ Scores (Primary Functional Outcome)', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.'}, {'measure': 'Changes in SF-12 Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.'}, {'measure': 'Changes in MOS SAS Scores', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.'}, {'measure': 'Changes in Sodium Intake (as Measured With the SSQ)', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily." It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher sodium intake.'}, {'measure': 'Changes in Self-Reported Medication Adherence (SRMA)', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks.'}, {'measure': 'Change in Physical Activity', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks.'}, {'measure': 'Change in Moderate to Vigorous Physical Activity', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks.'}, {'measure': 'Feasibility of Actigraph', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Positive Psychology', 'Adherence to Health Behaviors'], 'conditions': ['Congestive Heart Failure', 'Emotions', 'Patient Compliance']}, 'referencesModule': {'references': [{'pmid': '33160091', 'type': 'DERIVED', 'citation': 'Celano CM, Freedman ME, Harnedy LE, Park ER, Januzzi JL, Healy BC, Huffman JC. Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study. J Psychosom Res. 2020 Dec;139:110285. doi: 10.1016/j.jpsychores.2020.110285. Epub 2020 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).', 'detailedDescription': "The investigators are proposing a study that will focus on the implementation of a novel PP-based health behavior intervention that is adapted for patients with HF. The MGH inpatient units, MGH Heart Center, and MGH primary care clinic outpatients will serve as the source of participants for the study, with patients who have a diagnosis of HF serving as potential participants. The investigators will enroll 60 HF patients, who will take part in a 12-week PP-based health behavior intervention.\n\nIn this project, the investigators hope to do the following:\n\n1. Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a three-arm, randomized, controlled pilot trial in patients with mild to moderate HF (N=60).\n2. Determine whether this optimized intervention is feasible in a small cohort of HF patients.\n3. Explore potential benefits of the intervention on outcomes of interest (e.g., psychological health, functioning, and health behavior adherence) compared to a motivational interviewing- (MI) based education condition and treatment as usual (TAU).\n\nBaseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery disease, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).\n\nParticipants will undergo two in person visits during which they will meet with study staff in person (or if preferred over the phone). In their first visit, they will answer questionnaires related to psychological and physical health and functioning and will be asked to wear an accelerometer for one week to measure their baseline physical activity. At their second in-person visit, they will be randomized to receive (1) the PP-based health behavior intervention, (2) the MI-based educational condition, or (3) TAU. Participants in the TAU group will not receive any additional intervention but will complete follow-up phone calls at 12 and 24 weeks.\n\nFollowing randomization, participants in the two treatment groups will be provided a treatment manual corresponding with their treatment condition with weekly exercises, along with a copy of the Learning to Live with Heart Failure guide. The appropriate intervention will be introduced, and the first exercise will be assigned. Finally, participants in both treatment groups will receive a personal step counter to use over the course of the study.\n\nFollowing the second in-person visit, participants in the PP-based intervention and MI-based control condition groups will complete twelve 30- to 45-minute weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.\n\nAt Weeks 12 and 24, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. At these two time points, participants also will be asked to wear an accelerometer for an additional 7 days to measure physical activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center or MGH-affiliated primary care clinic. Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them to increase physical activity and other health behaviors; therefore, they will not be included. HF diagnosis will be confirmed via chart review and with the patient's treatment team as needed.\n* Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications. The MOS has been used in multiple prior studies assessing adherence in cardiac patients, including our own studies in this population. This threshold score on the MOS will ensure that all participants will have the potential to improve their health behaviors.\n\nExclusion Criteria:\n\n* Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research participants.\n* Medical conditions precluding interviews or likely to lead to death within 6 months.\n* Inability to speak English, inability to read or write, inability to walk, or lack of a telephone."}, 'identificationModule': {'nctId': 'NCT03220204', 'acronym': 'REACH III', 'briefTitle': 'Researching Emotions And Cardiac Health: Phase III', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '5K23HL123607-03', 'link': 'https://reporter.nih.gov/quickSearch/5K23HL123607-03', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5K23HL123607-03', 'link': 'https://reporter.nih.gov/quickSearch/5K23HL123607-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PP-based health behavior intervention', 'description': "Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.", 'interventionNames': ['Behavioral: PP-based health behavior intervention']}, {'type': 'EXPERIMENTAL', 'label': 'MI-based educational control condition', 'description': 'Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. This Motivational Interviewing (MI)-based educational control condition will introduce these participants to motivational interviewing topics in concert with the health behavior education topics.', 'interventionNames': ['Behavioral: MI-based educational control condition']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.'}], 'interventions': [{'name': 'PP-based health behavior intervention', 'type': 'BEHAVIORAL', 'description': 'The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.', 'armGroupLabels': ['PP-based health behavior intervention']}, {'name': 'MI-based educational control condition', 'type': 'BEHAVIORAL', 'description': 'The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.', 'armGroupLabels': ['MI-based educational control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Christopher Celano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Psychiatrist', 'investigatorFullName': 'Christopher Celano', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}