Trial Outcomes & Findings for The Health Access and Recovery Peer Program (NCT NCT01725815)
NCT ID: NCT01725815
Last Updated: 2019-10-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
Baseline, 3 months post-intervention, 6 months post-intervention
Results posted on
2019-10-09
Participant Flow
Participant milestones
| Measure |
HARP Intervention
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: Control
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
202
|
|
Overall Study
COMPLETED
|
198
|
202
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Health Access and Recovery Peer Program
Baseline characteristics by cohort
| Measure |
HARP Intervention
n=198 Participants
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: Control
n=202 Participants
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.74 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
49.69 years
STANDARD_DEVIATION 9.51 • n=7 Participants
|
49.71 years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
131 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
202 participants
n=7 Participants
|
400 participants
n=5 Participants
|
|
Total annual Income
$0-$5000
|
96 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Total annual Income
$5000-$10000
|
53 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Total annual Income
$10000-$15000
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Total annual Income
>$15000
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Total annual Income
Unknown
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Insurance status
Medicaid
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Insurance status
Medicare
|
38 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Insurance status
Private insurance
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Insurance status
Unknown
|
98 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Medical Diagnosis
Diabetes
|
51 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Medical Diagnosis
Heart Disease/CAD/CHD
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Medical Diagnosis
Hyperlipidemia
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Medical Diagnosis
Hypertension
|
133 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Medical Diagnosis
Arthritis
|
93 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Medical Diagnosis
Hepatitis
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Medical Diagnosis
Asthma/COPD
|
65 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Medical Diagnosis
HIV
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Primary Mental Diagnosis
Schizophrenia/Schizoaffective
|
52 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Primary Mental Diagnosis
Bipolar Disorder
|
74 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Primary Mental Diagnosis
Depression
|
141 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Primary Mental Diagnosis
Obsessive Compulsive Disorder
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Primary Mental Diagnosis
Post-Traumatic stress Disorder
|
43 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-interventionThe 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.
Outcome measures
| Measure |
HARP Intervention
n=198 Participants
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: Control
n=202 Participants
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
|---|---|---|
|
Health Related Quality of Life (HRQOL)
Baseline
|
32.73 score on a scale
Standard Deviation 10.92
|
32.74 score on a scale
Standard Deviation 11.29
|
|
Health Related Quality of Life (HRQOL)
3 months post-intervention
|
34.49 score on a scale
Standard Deviation 11.15
|
33.89 score on a scale
Standard Deviation 10.41
|
|
Health Related Quality of Life (HRQOL)
6 months post-intervention
|
35.42 score on a scale
Standard Deviation 11.02
|
34.15 score on a scale
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-interventionBehavioral 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).
Outcome measures
| Measure |
HARP Intervention
n=198 Participants
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: Control
n=202 Participants
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
|---|---|---|
|
Behavioral Activation
Baseline
|
57.4 score on a scale
Standard Deviation 16.6
|
55.7 score on a scale
Standard Deviation 14.9
|
|
Behavioral Activation
3 months post-intervention
|
61.6 score on a scale
Standard Deviation 15.9
|
56.4 score on a scale
Standard Deviation 16.5
|
|
Behavioral Activation
6 months post-intervention
|
60.5 score on a scale
Standard Deviation 16.7
|
57.2 score on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-interventionDietary 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).
Outcome measures
| Measure |
HARP Intervention
n=198 Participants
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: Control
n=202 Participants
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
|---|---|---|
|
Dietary Intake
Baseline
|
10.1 score on a scale
Standard Deviation 5.1
|
9.8 score on a scale
Standard Deviation 5.6
|
|
Dietary Intake
3 months post-intervention
|
10.1 score on a scale
Standard Deviation 5.0
|
9.3 score on a scale
Standard Deviation 5.3
|
|
Dietary Intake
6 months post-intervention
|
10.2 score on a scale
Standard Deviation 5.6
|
9.4 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-interventionMedication 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.
Outcome measures
| Measure |
HARP Intervention
n=198 Participants
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: Control
n=202 Participants
Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
|
|---|---|---|
|
Medication Adherence
Baseline
|
0.92 score on a scale
Standard Deviation 0.94
|
0.94 score on a scale
Standard Deviation 1.02
|
|
Medication Adherence
3 months post-intervention
|
0.79 score on a scale
Standard Deviation 0.92
|
0.97 score on a scale
Standard Deviation 0.96
|
|
Medication Adherence
6 months post-intervention
|
0.84 score on a scale
Standard Deviation 0.92
|
0.89 score on a scale
Standard Deviation 0.96
|
Adverse Events
HARP Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place