The Health Access and Recovery Peer Program (HARP)
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|ClinicalTrials.gov Identifier: NCT01725815|
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : July 13, 2017
Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and also challenges in effectively managing these health problems. There is an urgent need to develop self-management strategies that allow persons with SMI to more effectively manage their chronic medical illnesses.
In general populations, peer-led disease self-management interventions have been demonstrated to be feasible, effective, scalable, and to lead to sustainable improvements in self-management and health outcomes. With funding from an R34 intervention development grant from NIMH, the study team has developed and piloted a modified version of the most widely tested and used peer-led self management program, the Chronic Disease Self-Management Program (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented with high engagement, retention, and program fidelity, and can result in effect sizes across a range of outcomes comparable to or greater than those seen in general medical populations.
This application proposes to conduct a fully-powered, multisite trial of the HARP program. A total of 400 individuals with serious mental illnesses and one or more chronic medical condition will be recruited from three diverse community mental health clinics in the Atlanta metro region and randomized to the HARP program or usual care. For individuals in the HARP program, two peer educators with SMI and one or more chronic medical condition will lead a six-session, six-week manualized intervention, which helps participants become more effective managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6 months and one year will assess changes in clinical outcomes, improvement in generic and disease-specific measures of illness self-management, and quality of care. During the final phase of the study, a dissemination strategy building on the CDSMP training infrastructure will allow program participants to lead HARP groups.
If successful, this study will establish the first fully peer-led, evidence-based intervention for improving physical self-management in this vulnerable population.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Arthritis Coronary Artery Disease Hepatitis Diabetes Asthma Hyperlipidemia HIV||Behavioral: HARP Intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||March 31, 2017|
|Experimental: HARP Intervention||
Behavioral: HARP Intervention
The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
|No Intervention: No Intervention: Control|
- Health related quality of life [ Time Frame: One Year ]
- Patient Activation [ Time Frame: One Year ]
- Health Behaviors [ Time Frame: One Year ]Health behaviors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725815
|United States, Georgia|
|Central Fulton Community Mental Health Center at Grady Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Benjamin Druss, MD, MPH||Emory University|