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Completed

NCT Number: NCT01725815

The Health Access and Recovery Peer Program

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.

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Key information

Conditions

Hypertension Arterial Occlusive Diseases Arteriosclerosis Arthritis Asthma Bronchial Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Diabetes Mellitus Digestive System Diseases Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders HIV Heart Diseases Hepatitis Hyperlipidemia Hyperlipidemias Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Joint Diseases Lipid Metabolism Disorders Liver Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Musculoskeletal Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Fulton Community Mental Health Center at Grady Hospital

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HARP Intervention

Behavioral

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.

Primary outcomes

  1. Health Related Quality of Life (HRQOL)

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

    The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.

Secondary outcomes

  1. Behavioral Activation

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

    Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).

  2. Dietary Intake

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

    Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).

  3. Medication Adherence

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

    Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers

Acronym: HARP

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Nov 14, 2012
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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