Arthritis, Asthma, Coronary Artery Disease, Diabetes, Hepatitis, HIV, Hyperlipidemia, Hypertension
Conditions
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.
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.
Interventions
BEHAVIORALHARP 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.
Sponsors
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 198 |
| No Intervention: Control Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving. | 202 |
| Total | 400 |
Baseline characteristics
| Characteristic | HARP Intervention | Total | No Intervention: Control |
|---|---|---|---|
| Age, Continuous | 49.74 years STANDARD_DEVIATION 8.72 | 49.71 years STANDARD_DEVIATION 9.11 | 49.69 years STANDARD_DEVIATION 9.51 |
| Insurance status Medicaid | 56 Participants | 116 Participants | 60 Participants |
| Insurance status Medicare | 38 Participants | 85 Participants | 47 Participants |
| Insurance status Private insurance | 6 Participants | 20 Participants | 14 Participants |
| Insurance status Unknown | 98 Participants | 179 Participants | 81 Participants |
| Medical Diagnosis Arthritis | 93 Participants | 172 Participants | 79 Participants |
| Medical Diagnosis Asthma/COPD | 65 Participants | 137 Participants | 72 Participants |
| Medical Diagnosis Diabetes | 51 Participants | 116 Participants | 65 Participants |
| Medical Diagnosis Heart Disease/CAD/CHD | 25 Participants | 45 Participants | 20 Participants |
| Medical Diagnosis Hepatitis | 19 Participants | 44 Participants | 25 Participants |
| Medical Diagnosis HIV | 6 Participants | 18 Participants | 12 Participants |
| Medical Diagnosis Hyperlipidemia | 81 Participants | 163 Participants | 82 Participants |
| Medical Diagnosis Hypertension | 133 Participants | 275 Participants | 142 Participants |
| Primary Mental Diagnosis Bipolar Disorder | 74 Participants | 154 Participants | 80 Participants |
| Primary Mental Diagnosis Depression | 141 Participants | 280 Participants | 139 Participants |
| Primary Mental Diagnosis Obsessive Compulsive Disorder | 12 Participants | 30 Participants | 18 Participants |
| Primary Mental Diagnosis Post-Traumatic stress Disorder | 43 Participants | 101 Participants | 58 Participants |
| Primary Mental Diagnosis Schizophrenia/Schizoaffective | 52 Participants | 114 Participants | 62 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 131 Participants | 264 Participants | 133 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) White | 60 Participants | 120 Participants | 60 Participants |
| Region of Enrollment United States | 198 participants | 400 participants | 202 participants |
| Sex: Female, Male Female | 132 Participants | 255 Participants | 123 Participants |
| Sex: Female, Male Male | 66 Participants | 145 Participants | 79 Participants |
| Total annual Income $0-$5000 | 96 Participants | 183 Participants | 87 Participants |
| Total annual Income $10000-$15000 | 26 Participants | 53 Participants | 27 Participants |
| Total annual Income >$15000 | 21 Participants | 45 Participants | 24 Participants |
| Total annual Income $5000-$10000 | 53 Participants | 113 Participants | 60 Participants |
| Total annual Income Unknown | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 198 | 0 / 202 |
| other Total, other adverse events | 0 / 198 | 0 / 202 |
| serious Total, serious adverse events | 0 / 198 | 0 / 202 |
Outcome results
Primary
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.
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HARP Intervention | Health Related Quality of Life (HRQOL) | Baseline | 32.73 score on a scale | Standard Deviation 10.92 |
| HARP Intervention | Health Related Quality of Life (HRQOL) | 3 months post-intervention | 34.49 score on a scale | Standard Deviation 11.15 |
| HARP Intervention | Health Related Quality of Life (HRQOL) | 6 months post-intervention | 35.42 score on a scale | Standard Deviation 11.02 |
| No Intervention: Control | Health Related Quality of Life (HRQOL) | Baseline | 32.74 score on a scale | Standard Deviation 11.29 |
| No Intervention: Control | Health Related Quality of Life (HRQOL) | 3 months post-intervention | 33.89 score on a scale | Standard Deviation 10.41 |
| No Intervention: Control | Health Related Quality of Life (HRQOL) | 6 months post-intervention | 34.15 score on a scale | Standard Deviation 11.52 |
Secondary
Behavioral Activation
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HARP Intervention | Behavioral Activation | Baseline | 57.4 score on a scale | Standard Deviation 16.6 |
| HARP Intervention | Behavioral Activation | 3 months post-intervention | 61.6 score on a scale | Standard Deviation 15.9 |
| HARP Intervention | Behavioral Activation | 6 months post-intervention | 60.5 score on a scale | Standard Deviation 16.7 |
| No Intervention: Control | Behavioral Activation | Baseline | 55.7 score on a scale | Standard Deviation 14.9 |
| No Intervention: Control | Behavioral Activation | 3 months post-intervention | 56.4 score on a scale | Standard Deviation 16.5 |
| No Intervention: Control | Behavioral Activation | 6 months post-intervention | 57.2 score on a scale | Standard Deviation 16.3 |
Secondary
Dietary Intake
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HARP Intervention | Dietary Intake | 6 months post-intervention | 10.2 score on a scale | Standard Deviation 5.6 |
| HARP Intervention | Dietary Intake | Baseline | 10.1 score on a scale | Standard Deviation 5.1 |
| HARP Intervention | Dietary Intake | 3 months post-intervention | 10.1 score on a scale | Standard Deviation 5 |
| No Intervention: Control | Dietary Intake | 6 months post-intervention | 9.4 score on a scale | Standard Deviation 5.3 |
| No Intervention: Control | Dietary Intake | Baseline | 9.8 score on a scale | Standard Deviation 5.6 |
| No Intervention: Control | Dietary Intake | 3 months post-intervention | 9.3 score on a scale | Standard Deviation 5.3 |
Secondary
Medication Adherence
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HARP Intervention | Medication Adherence | Baseline | 0.92 score on a scale | Standard Deviation 0.94 |
| HARP Intervention | Medication Adherence | 3 months post-intervention | 0.79 score on a scale | Standard Deviation 0.92 |
| HARP Intervention | Medication Adherence | 6 months post-intervention | 0.84 score on a scale | Standard Deviation 0.92 |
| No Intervention: Control | Medication Adherence | Baseline | 0.94 score on a scale | Standard Deviation 1.02 |
| No Intervention: Control | Medication Adherence | 3 months post-intervention | 0.97 score on a scale | Standard Deviation 0.96 |
| No Intervention: Control | Medication Adherence | 6 months post-intervention | 0.89 score on a scale | Standard Deviation 0.96 |