Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-13 @ 7:51 AM
Study NCT ID:
NCT02087956
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Realizing Opportunities for Self Empowerment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ellen_poleshuck@urmc.rochester.edu', 'phone': '585-275-3138', 'title': 'Dr. Ellen Poleshuck', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': 'Enhanced Screen and Referral (ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}, {'id': 'OG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.51', 'spread': '13.82', 'groupId': 'OG000'}, {'value': '76.91', 'spread': '13.70', 'groupId': 'OG001'}]}]}, {'title': 'post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.70', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '78.85', 'spread': '15.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post treatment (4 months after enrollment)', 'description': 'We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment.\n\nThe WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual\'s perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are presented for WHO-QOL total score. We had attrition of about 5% throughout the study, therefore number of analyzed at post treatment differs from initial number of participants.'}, {'type': 'PRIMARY', 'title': 'Depression Change Outcome Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}, {'id': 'OG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.92', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '14.74', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.61', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '12.58', 'spread': '6.56', 'groupId': 'OG001'}]}]}, {'title': '3 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.14', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '11.39', 'spread': '6.45', 'groupId': 'OG001'}]}]}, {'title': '6 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.21', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '10.36', 'spread': '6.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)', 'description': 'Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We had 5% attrition throughout the study, therefore number of subjects differ at each assessment point.'}, {'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire- 8 Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}, {'id': 'OG001', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}], 'classes': [{'title': 'CSQ 1. post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'CSQ 1. 3 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'CSQ 1. 6 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: "How would you rate the quality of service you have received?", CSQ 3: "To what extent has our program met your needs?", CSQ 6: "Have the services you received helped you to deal more effectively with your problems?" and CSQ 7: "In an overall, general sense, how satisfied are you with the service you have received?" (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We had attrition of about 5% throughout the study, therefor number of analyzed at post treatment differs from initial number of participants'}, {'type': 'SECONDARY', 'title': 'Domestic Violence (Feldhaus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}, {'id': 'OG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}], 'classes': [{'title': 'DV_baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'DV_post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'DV_3 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'DV_6 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)', 'description': 'Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We had attrition of 5% throughout the study; additionally we had some missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}, {'id': 'FG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.\n\nNavigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.'}, {'id': 'BG001', 'title': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.\n\nEnhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AA/Black', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latina', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Other (Native American, Asian, Hawaiian)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Biracial/More than one race', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Our demographic measure included both race and ethnicity (Hispanic/Latina) in one category.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Our sample doesn\'t add up to 100% because our participant could check "all that apply" for race/ethnicity.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'We enrolled 223 participants into this study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2014-03-12', 'resultsFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2014-03-13', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-03', 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Quality of Life', 'timeFrame': 'Post treatment (4 months after enrollment)', 'description': 'We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment.\n\nThe WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual\'s perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.'}, {'measure': 'Depression Change Outcome Measure', 'timeFrame': 'baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)', 'description': 'Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.'}, {'measure': 'Client Satisfaction Questionnaire- 8 Items', 'timeFrame': 'Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: "How would you rate the quality of service you have received?", CSQ 3: "To what extent has our program met your needs?", CSQ 6: "Have the services you received helped you to deal more effectively with your problems?" and CSQ 7: "In an overall, general sense, how satisfied are you with the service you have received?" (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome.'}], 'secondaryOutcomes': [{'measure': 'Domestic Violence (Feldhaus)', 'timeFrame': 'baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)', 'description': 'Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Women', 'Depression', 'Socioeconomically Disadvantaged', 'Navigation'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether priority-based patient navigation will improve patient satisfaction, quality of life (QOL), and depression when compared to screening-and-referral for socioeconomically disadvantaged women's health patients with depression. The investigators goal is to establish patient-driven, effective, generalizable, and disseminable interventions to reduce depression-related disparities and improve outcomes.", 'detailedDescription': "* In this comparative effectiveness study, 200 participants who are patients at the University of Rochester Women's Health Practice or Highland Woman's Health and report significant depressive symptoms will be randomized to either PSP (Personal Support for Progress) or ESR (Enhanced Screening and Referral). Participants assigned to PSP will work with a patient navigator to prioritize their concerns, develop a personalized care plan, and implement their plan. Participants assigned to ESR will receive a personalized report of community resources that may be helpful for their identified needs.\n* The investigators will use a simple 1:1 randomized design with treatment assignment being conducted using a random number generator. All analyses will follow an intent-to-treat protocol, such that all participants randomized will be followed for data collection and analyzed according to her randomized condition\n* Each participant will be assessed 4 times for outcome changes: at baseline, post treatment (4 months), and two follow up ( at 7 and 10 months).\n* Assessments are self report on iPads and they are linked directly to a Red Cap database."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with depression (PHQ9 score 10 or higher)\n* Patient of University of Rochester Women's Health Practice or Highland Women's Health\n* Monroe County resident\n* English speaking\n\nExclusion Criteria:\n\n* Currently receiving case management services\n* In need of acute psychiatric services\n* Unable to commit to the duration of the project"}, 'identificationModule': {'nctId': 'NCT02087956', 'acronym': 'ROSE', 'briefTitle': 'Realizing Opportunities for Self Empowerment', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression', 'orgStudyIdInfo': {'id': 'AD-12-11-4261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Personalized Support for Progress (PSP)', 'description': 'In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.', 'interventionNames': ['Behavioral: Navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Screening and Referral (ESR)', 'description': '(ESR)- participant will receive personal report of their current needs and list of resources available in the community.', 'interventionNames': ['Behavioral: Enhanced Screening and Referral']}], 'interventions': [{'name': 'Navigation', 'type': 'BEHAVIORAL', 'otherNames': ['mentoring'], 'description': 'The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.', 'armGroupLabels': ['Personalized Support for Progress (PSP)']}, {'name': 'Enhanced Screening and Referral', 'type': 'BEHAVIORAL', 'otherNames': ['Comprehensise health result screening'], 'description': 'Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.', 'armGroupLabels': ['Enhanced Screening and Referral (ESR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester, Women Health Practice', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Ellen Poleshuck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Women's Behavioral Health Service; Associate Professor, Departments of Psychiatry and Obstetrics & Gynecology", 'investigatorFullName': 'Ellen Poleshuck', 'investigatorAffiliation': 'University of Rochester'}}}}