The Health Access and Recovery Peer Program (HARP)

This study is currently recruiting participants.
Verified November 2013 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: November 18, 2013
Last verified: November 2013

April 25, 2012
November 18, 2013
June 2011
April 2015   (final data collection date for primary outcome measure)
Health related quality of life [ Time Frame: One Year ] [ Designated as safety issue: No ]
Health related quality of life [ Time Frame: One Year ] [ Designated as safety issue: No ]
The SF-36 is a measure of Health Related Quality Of Life constructed for use in the Medical Outcomes Study. The Physical Component Summary Score is an aggregate measure that combines subscales for physical functioning, bodily pain, and general self-reported health. This will be used as the primary study outcome because it is able to capture multiple domains of health and functioning targeted by disease management programs, and is predictive of other distal health outcomes including hospitalization and mortality. It is possible that the intervention will have particular benefits for specific domains of physical health related quality of life, and also that it might have benefits for mental health and functioning. Therefore we will also examine the intervention's impact on each of the four subscales that make up the Physical Component Summary Score, the four mental health subscales, and the Mental Component Summary.
Complete list of historical versions of study NCT01725815 on ClinicalTrials.gov Archive Site
  • Patient Activation [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Health Behaviors [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Health behaviors
  • Behavior Activation [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Behavioral Activation will be measured using the Patient Activation Measure, an instrument which has been found to be reliable and valid across a wide range of patient populations.
  • Health Behaviors [ Time Frame: One Year ]
    Health behaviors: Dietary intake will be Kristal Fat and Fiber Behavior scale, a validated 20-item scale assessing behavior related to low-fat eating, and the Block Fat-Sugar-Fruit-Vegetable Screener which assesses both frequency and quantity of food intake based on typical eating habits. Physical Activity will be assessed with the International Physical Activity Questionnaire, a one-week recall measure of physical activity that includes domains for job-related, transportation, housework and family care, recreation domains, as well as time spent sitting, and the Paffenbarger questionnaire, which quantifies the number of calories people expend per week in physical activities.
Not Provided
Not Provided
 
The Health Access and Recovery Peer Program
A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Arthritis
  • Coronary Artery Disease
  • Hepatitis
  • Diabetes
  • Asthma
  • Hyperlipidemia
  • HIV
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.
  • Experimental: HARP Intervention
    Intervention: Behavioral: HARP Intervention
  • No Intervention: No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2016
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gretl Glick 404-783-1061 gglick@emory.edu
Contact: Silke von Esenwein, PhD 404-712-8525 svonese@emory.edu
United States
 
NCT01725815
IRB00047631a, 1R01MH090584-01A1
Yes
Benjamin Druss, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Benjamin Druss, MD, MPH Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP