The Health Access and Recovery Peer Program

NCT01725815 | Completed Results DMC

• 2 other identifiers: IRB00047631a1R01MH090584-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Arthritis; Coronary Artery Disease; Hepatitis; Diabetes; Asthma; Hyperlipidemia; HIV

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life (HRQOL)

  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.

  Baseline, 3 months post-intervention, 6 months post-intervention

Secondary Outcomes (3)

• Behavioral Activation

  Baseline, 3 months post-intervention, 6 months post-intervention

• Dietary Intake

  Baseline, 3 months post-intervention, 6 months post-intervention

• Medication Adherence

  Baseline, 3 months post-intervention, 6 months post-intervention

Study Arms (2)

HARP Intervention

EXPERIMENTAL

Behavioral: HARP Intervention

No Intervention: Control

NO INTERVENTION

Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.

Interventions

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.

HARP Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Central Fulton Community Mental Health Center at Grady Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Hypertension; Arthritis; Coronary Artery Disease; Hepatitis; Diabetes Mellitus; Asthma; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Joint Diseases; Musculoskeletal Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Results Point of Contact

• Title: Dr. Benjamin Druss
• Organization: Emory University

bdruss@emory.edu

404-712-9602

Study Officials

• Benjamin Druss, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: November 14, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: March 31, 2017
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Locations

US (1)