HARP: The Health Access and Recovery Peer Program
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
Outcome Measures
Primary Outcome Measures
- Health Related Quality of Life (HRQOL) [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 Outcome Measures
- Behavioral Activation [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).
- Dietary Intake [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).
- Medication Adherence [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Fulton Community Mental Health Center at Grady Hospital | Atlanta | Georgia | United States | 30303 |
Sponsors and Collaborators
- Emory University
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Benjamin Druss, MD, MPH, Emory University
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00047631a
- 1R01MH090584-01A1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | HARP Intervention | No Intervention: Control |
|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
| Period Title: Overall Study | ||
| STARTED | 198 | 202 |
| COMPLETED | 198 | 202 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | HARP Intervention | No Intervention: Control | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. | Total of all reporting groups |
| Overall Participants | 198 | 202 | 400 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
49.74
(8.72)
|
49.69
(9.51)
|
49.71
(9.11)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
132
66.7%
|
123
60.9%
|
255
63.8%
|
| Male |
66
33.3%
|
79
39.1%
|
145
36.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
131
66.2%
|
133
65.8%
|
264
66%
|
| White |
60
30.3%
|
60
29.7%
|
120
30%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
7
3.5%
|
9
4.5%
|
16
4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
198
100%
|
202
100%
|
400
100%
|
| Total annual Income (Count of Participants) | |||
| $0-$5000 |
96
48.5%
|
87
43.1%
|
183
45.8%
|
| $5000-$10000 |
53
26.8%
|
60
29.7%
|
113
28.3%
|
| $10000-$15000 |
26
13.1%
|
27
13.4%
|
53
13.3%
|
| >$15000 |
21
10.6%
|
24
11.9%
|
45
11.3%
|
| Unknown |
2
1%
|
4
2%
|
6
1.5%
|
| Insurance status (Count of Participants) | |||
| Medicaid |
56
28.3%
|
60
29.7%
|
116
29%
|
| Medicare |
38
19.2%
|
47
23.3%
|
85
21.3%
|
| Private insurance |
6
3%
|
14
6.9%
|
20
5%
|
| Unknown |
98
49.5%
|
81
40.1%
|
179
44.8%
|
| Medical Diagnosis (Count of Participants) | |||
| Diabetes |
51
25.8%
|
65
32.2%
|
116
29%
|
| Heart Disease/CAD/CHD |
25
12.6%
|
20
9.9%
|
45
11.3%
|
| Hyperlipidemia |
81
40.9%
|
82
40.6%
|
163
40.8%
|
| Hypertension |
133
67.2%
|
142
70.3%
|
275
68.8%
|
| Arthritis |
93
47%
|
79
39.1%
|
172
43%
|
| Hepatitis |
19
9.6%
|
25
12.4%
|
44
11%
|
| Asthma/COPD |
65
32.8%
|
72
35.6%
|
137
34.3%
|
| HIV |
6
3%
|
12
5.9%
|
18
4.5%
|
| Primary Mental Diagnosis (Count of Participants) | |||
| Schizophrenia/Schizoaffective |
52
26.3%
|
62
30.7%
|
114
28.5%
|
| Bipolar Disorder |
74
37.4%
|
80
39.6%
|
154
38.5%
|
| Depression |
141
71.2%
|
139
68.8%
|
280
70%
|
| Obsessive Compulsive Disorder |
12
6.1%
|
18
8.9%
|
30
7.5%
|
| Post-Traumatic stress Disorder |
43
21.7%
|
58
28.7%
|
101
25.3%
|
Outcome Measures
| Title | Health Related Quality of Life (HRQOL) |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3 months post-intervention, 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HARP Intervention | No Intervention: Control |
|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
| Measure Participants | 198 | 202 |
| Baseline |
32.73
(10.92)
|
32.74
(11.29)
|
| 3 months post-intervention |
34.49
(11.15)
|
33.89
(10.41)
|
| 6 months post-intervention |
35.42
(11.02)
|
34.15
(11.52)
|
| Title | Behavioral Activation |
|---|---|
| Description | 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). |
| Time Frame | Baseline, 3 months post-intervention, 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HARP Intervention | No Intervention: Control |
|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
| Measure Participants | 198 | 202 |
| Baseline |
57.4
(16.6)
|
55.7
(14.9)
|
| 3 months post-intervention |
61.6
(15.9)
|
56.4
(16.5)
|
| 6 months post-intervention |
60.5
(16.7)
|
57.2
(16.3)
|
| Title | Dietary Intake |
|---|---|
| Description | 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). |
| Time Frame | Baseline, 3 months post-intervention, 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HARP Intervention | No Intervention: Control |
|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
| Measure Participants | 198 | 202 |
| Baseline |
10.1
(5.1)
|
9.8
(5.6)
|
| 3 months post-intervention |
10.1
(5.0)
|
9.3
(5.3)
|
| 6 months post-intervention |
10.2
(5.6)
|
9.4
(5.3)
|
| Title | Medication Adherence |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3 months post-intervention, 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HARP Intervention | No Intervention: Control |
|---|---|---|
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. |
| Measure Participants | 198 | 202 |
| Baseline |
0.92
(0.94)
|
0.94
(1.02)
|
| 3 months post-intervention |
0.79
(0.92)
|
0.97
(0.96)
|
| 6 months post-intervention |
0.84
(0.92)
|
0.89
(0.96)
|
Adverse Events
| Time Frame | 3 months post-intervention, 6 months post-intervention | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | HARP Intervention | No Intervention: Control | ||
| Arm/Group Description | 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. | Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. | ||
All Cause Mortality |
||||
| HARP Intervention | No Intervention: Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/198 (0%) | 0/202 (0%) | ||
Serious Adverse Events |
||||
| HARP Intervention | No Intervention: Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/198 (0%) | 0/202 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| HARP Intervention | No Intervention: Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/198 (0%) | 0/202 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Benjamin Druss |
|---|---|
| Organization | Emory University |
| Phone | 404-712-9602 |
| bdruss@emory.edu |
- IRB00047631a
- 1R01MH090584-01A1