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The Health Access and Recovery Peer Program (HARP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Druss, Emory University
ClinicalTrials.gov Identifier:
NCT01725815
First received: April 25, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hypertension
Arthritis
Coronary Artery Disease
Hepatitis
Diabetes
Asthma
Hyperlipidemia
HIV
Behavioral: HARP Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Activation [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Health Behaviors [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Health behaviors


Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725815

Contacts
Contact: Stephanie Tapscott 404-615-9883 gglick@emory.edu
Contact: Gretl Glick 404-712-8529 gglick@emory.edu

Locations
United States, Georgia
Central Fulton Community Mental Health Center at Grady Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Gretl Glick    404-783-1061    gglick@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Benjamin Druss, MD, MPH Emory University
  More Information

No publications provided

Responsible Party: Benjamin Druss, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01725815     History of Changes
Other Study ID Numbers: IRB00047631a, 1R01MH090584-01A1
Study First Received: April 25, 2012
Last Updated: May 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Hyperlipidemias
Hypertension
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014