Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-10 @ 4:52 PM
Study NCT ID:
NCT02894502
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ercole.vellone@uniroma2.it', 'phone': '+393387491811', 'title': 'Dr. Ercole Vellone', 'organization': 'University of Rome Tor vergata, Rome, Italy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one year', 'description': 'In this study we considered only all-cause mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this arm the interventions will be delivered only to patients\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 155, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Motivational Interviewing to Patients and Caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 177, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'This Group will receive the usual care', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 178, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-care Maintenance in Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this arm the interventions will be delivered only to patients\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'OG001', 'title': 'Motivational Interviewing to Patients and Caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'This Group will receive the usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '52.36', 'spread': '22.67', 'groupId': 'OG000'}, {'value': '54.23', 'spread': '20.36', 'groupId': 'OG001'}, {'value': '49.63', 'spread': '17.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months from the intervention', 'description': 'Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Burden of HF Symptoms in Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this Arm, motivational interviewing will be provided only to patients'}, {'id': 'OG001', 'title': 'Motivational Interviewing for Patients and Caregivers', 'description': 'In this Arm, motivational interviewing will be provided to patients and caregivers'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'This Arm will receive the standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '22.5', 'spread': '21.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with heart failure'}, {'type': 'SECONDARY', 'title': 'Patient and Caregiver Generic Physical and Mental Quality of Life', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient and Caregiver Anxiety and Depression', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient HF Specific Quality of Life', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient and Caregiver Quality of Nocturnal Sleep', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Pittsburgh Sleep Quality Index', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient and Caregiver Mutuality', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Mutuality Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Preparedness', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Perceived Social Support', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Multidimensional Scale of Perceived Social Support Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient Hospitalizations', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Use of Emergency Services', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this arm the interventions will be delivered only to patients\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'OG001', 'title': 'Motivational Interviewing to Patients and Caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'This Group will receive the usual care'}], 'classes': [{'title': '3 month follow-up', 'categories': [{'title': 'Overall Number of Participants Analyzed', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}, {'title': 'Number of Deaths', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Number of refusals to continue the study', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': '6 month follow-up', 'categories': [{'title': 'Overall Number of Participants Analyzed', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}, {'title': 'Number of Deaths', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Number of refusals to continue the study', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': '9 month follow-up', 'categories': [{'title': 'Overall Number of Participants Analyzed', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}, {'title': 'Number of Deaths', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Number of refusals to continue the study', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': '12 month follow-up', 'categories': [{'title': 'Overall Number of Participants Analyzed', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}, {'title': 'Number of Deaths', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Number of refusals to continue the study', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The above participants were those who were randomized initially in the three arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this arm the interventions will be delivered only to patients\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'FG001', 'title': 'Motivational Interviewing to Patients and Caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'This Group will receive the usual care'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}, {'title': 'First Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '133'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}, {'title': 'Second Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Third Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Motivational Interviewing Only for Patients', 'description': 'In this arm the interventions will be delivered only to patients\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'BG001', 'title': 'Motivational Interviewing to Patients and Caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers\n\nMotivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'This Group will receive the usual care'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '508', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '381', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '508', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72.19', 'spread': '12.29', 'groupId': 'BG000'}, {'value': '72.45', 'spread': '10.79', 'groupId': 'BG001'}, {'value': '72.45', 'spread': '13.66', 'groupId': 'BG002'}, {'value': '72.37', 'spread': '12.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'In the first and in the third arm we have missing data'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', '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': 'Self-Care of Heart Failure Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45.72', 'spread': '15.23', 'groupId': 'BG000'}, {'value': '45.98', 'spread': '16.35', 'groupId': 'BG001'}, {'value': '44.98', 'spread': '14.61', 'groupId': 'BG002'}, {'value': '45.55', 'spread': '15.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Score of the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index (SCHFI) (primary endpoint). The SCHFI has three scales: Self-Care Maintenance, Self-Care Management and Self-Care Confidence. Each scale has a score from 0 to 100 with higher score meaning better self-care. Self-Care is considered adequate when patients have a score at each scale of 70 at least.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Failure Somatic Perception Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30.55', 'spread': '18.20', 'groupId': 'BG000'}, {'value': '30.18', 'spread': '18.25', 'groupId': 'BG001'}, {'value': '31.83', 'spread': '18.95', 'groupId': 'BG002'}, {'value': '30.87', 'spread': '18.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Heart Failure Somatic Perception Scale has a score between 0 and 90 with higher scores meaning more discomfort caused by heart failure symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SF-12 (Physical Component Summary)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36.01', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '35.01', 'spread': '9.16', 'groupId': 'BG001'}, {'value': '35.42', 'spread': '9.30', 'groupId': 'BG002'}, {'value': '35.46', 'spread': '9.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-12 (Physical Component Summary) measures the physical aspects of health-related quality of life. The score ranges between 0 and 100 with higher score indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-09', 'size': 263171, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-10T03:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2016-08-26', 'resultsFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2016-09-03', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-06', 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care Maintenance in Patients', 'timeFrame': '3 months from the intervention', 'description': 'Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.'}], 'secondaryOutcomes': [{'measure': 'Burden of HF Symptoms in Patients', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure.'}, {'measure': 'Patient and Caregiver Generic Physical and Mental Quality of Life', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).'}, {'measure': 'Patient and Caregiver Anxiety and Depression', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale'}, {'measure': 'Patient HF Specific Quality of Life', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire'}, {'measure': 'Patient and Caregiver Quality of Nocturnal Sleep', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Pittsburgh Sleep Quality Index'}, {'measure': 'Patient and Caregiver Mutuality', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Mutuality Scale'}, {'measure': 'Caregiver Preparedness', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale'}, {'measure': 'Caregiver Perceived Social Support', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'We will use the Multidimensional Scale of Perceived Social Support Scale'}, {'measure': 'Patient Hospitalizations', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention.'}, {'measure': 'Use of Emergency Services', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention.'}, {'measure': 'Death', 'timeFrame': '3, 6, 9 and 12 months from the intervention', 'description': 'Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Self-care', 'Motivational interviewing', 'Heart failure', 'Caregivers'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '28185994', 'type': 'BACKGROUND', 'citation': "Vellone E, Paturzo M, D'Agostino F, Petruzzo A, Masci S, Ausili D, Rebora P, Alvaro R, Riegel B. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:34-38. doi: 10.1016/j.cct.2017.02.003. Epub 2017 Feb 7."}, {'pmid': '32343483', 'type': 'RESULT', 'citation': 'Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309-1318. doi: 10.1002/ehf2.12733. Epub 2020 Apr 28.'}, {'pmid': '40780724', 'type': 'DERIVED', 'citation': 'Iovino P, Dollaku H, Alvaro R, Pucciarelli G, Rasero L, Macchi C, Liuzzi P, Riegel B, Vellone E. Sleep quality patterns in patients with heart failure: a person-centred latent class analysis from a secondary analysis of the MOTIVATE-HF trial. BMJ Open. 2025 Aug 8;15(8):e101950. doi: 10.1136/bmjopen-2025-101950.'}, {'pmid': '40013908', 'type': 'DERIVED', 'citation': 'Iovino P, Dollaku H, Rasero L, Uchmanowicz I, Alvaro R, Pucciarelli G, Vellone E. Psychometric Testing of the Kansas City Cardiomyopathy Questionnaire 12 in A European Population. J Cardiovasc Nurs. 2025 Feb 27;40(6):E374-82. doi: 10.1097/JCN.0000000000001187. Online ahead of print.'}, {'pmid': '38470867', 'type': 'DERIVED', 'citation': 'Caggianelli G, Alivernini F, Chirico A, Iovino P, Lucidi F, Uchmanowicz I, Rasero L, Alvaro R, Vellone E. The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis. PLoS One. 2024 Mar 12;19(3):e0300101. doi: 10.1371/journal.pone.0300101. eCollection 2024.'}, {'pmid': '37550831', 'type': 'DERIVED', 'citation': 'Locatelli G, Iovino P, Jurgens CY, Alvaro R, Uchmanowicz I, Rasero L, Riegel B, Vellone E. The Influence of Caregiver Contribution to Self-care on Symptom Burden in Patients With Heart Failure and the Mediating Role of Patient Self-care: A Longitudinal Mediation Analysis. J Cardiovasc Nurs. 2024 May-Jun 01;39(3):255-265. doi: 10.1097/JCN.0000000000001024. Epub 2023 Aug 8.'}, {'pmid': '37204336', 'type': 'DERIVED', 'citation': 'Locatelli G, Rebora P, Occhino G, Ausili D, Riegel B, Cammarano A, Uchmanowicz I, Alvaro R, Vellone E, Zeffiro V. The Impact of an Intervention to Improve Caregiver Contribution to Heart Failure Self-care on Caregiver Anxiety, Depression, Quality of Life, and Sleep. J Cardiovasc Nurs. 2023 May 18;38(4):361-9. doi: 10.1097/JCN.0000000000000998. Online ahead of print.'}, {'pmid': '37027137', 'type': 'DERIVED', 'citation': 'Spedale V, Fabrizi D, Rebora P, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):E98-E109. doi: 10.1097/JCN.0000000000000929. Epub 2022 May 31.'}, {'pmid': '35290454', 'type': 'DERIVED', 'citation': 'Locatelli G, Zeffiro V, Occhino G, Rebora P, Caggianelli G, Ausili D, Alvaro R, Riegel B, Vellone E. Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Nov 23;21(8):801-811. doi: 10.1093/eurjcn/zvac013.'}, {'pmid': '34571194', 'type': 'DERIVED', 'citation': 'Caggianelli G, Iovino P, Rebora P, Occhino G, Zeffiro V, Locatelli G, Ausili D, Alvaro R, Riegel B, Vellone E. A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial. J Pain Symptom Manage. 2022 Feb;63(2):221-229.e1. doi: 10.1016/j.jpainsymman.2021.09.006. Epub 2021 Sep 25.'}, {'pmid': '33616815', 'type': 'DERIVED', 'citation': 'Rebora P, Spedale V, Occhino G, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial. Qual Life Res. 2021 Jul;30(7):1939-1949. doi: 10.1007/s11136-021-02788-3. Epub 2021 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nDiagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).\n\nExclusion criteria:\n\nSevere cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).'}, 'identificationModule': {'nctId': 'NCT02894502', 'acronym': 'MOTIVATE-HF', 'briefTitle': 'MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '121/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational interviewing only for patients', 'description': 'In this arm the interventions will be delivered only to patients', 'interventionNames': ['Behavioral: Motivational interviewing']}, {'type': 'EXPERIMENTAL', 'label': 'Motivational interviewing to patients and caregivers', 'description': 'In this arm the interventions will be delivered both to patients and caregivers', 'interventionNames': ['Behavioral: Motivational interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This Group will receive the usual care'}], 'interventions': [{'name': 'Motivational interviewing', 'type': 'BEHAVIORAL', 'description': 'The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.', 'armGroupLabels': ['Motivational interviewing only for patients', 'Motivational interviewing to patients and caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00135', 'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'In case there will be the possibility to share the data, this will be done after data de-identification'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center of Excellence for Nursing Scholarship', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ercole Vellone', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}