Clinical trial NCT01725815: The Health Access and Recovery Peer Program
Official title: A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Arthritis
Coronary Artery Disease
Hepatitis
Diabetes
Asthma
Hyperlipidemia
HIV
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with serious mental illnesses (SMI) face high rates of medical comorbidity as well as challenges in managing these conditions. A growing workforce of certified peer specialists is available to help these individuals more effectively manage their health and health care. However, there is little existing research examining the effectiveness of peer-led medical self-management programs for this population. in this trial, participants were randomized to either the Health and Recovery Peer program (HARP), a medical disease self-management program led by certified peer specialists, or to care as usual. Assessments were conducted at baseline, 3 months, and 6 months.

Detailed description: 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.

This study will establish the first fully peer-led, evidence-based intervention for improving physical self-management in this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* On CMHC roster of active patients.
* Presence of a serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression, obsessive-compulsive disorder, or post-traumatic stress disorder
* Chronic Medical Condition as noted in the CMHC chart or via self-report: (hypertension; arthritis; heart disease; diabetes; and asthma/COPD),

Exclusion Criteria:

* cognitive impairment based on a score of \> 3 on a 6-item, validated screener developed for clinical research

Primary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention
Secondary outcomes:
measure: Behavioral Activation
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention
measure: Dietary Intake
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention
measure: Medication Adherence
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Central Fulton Community Mental Health Center at Grady Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Benjamin Druss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: