HypertensionHARPNCT01725815
The Health Access and Recovery Peer Program
A study testing HARP Intervention in people with Hypertension and Arthritis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Arthritis, Coronary Artery Disease
- What is being tested?
- HARP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- cognitive impairment based on a score of > 3 on a 6-item, validated screener developed for clinical research
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Fulton Community Mental Health Center at Grady Hospital
Atlanta, Georgia, 30303
About this study
Official title: A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
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.
Read the 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.
- Conditions
- Hypertension, Arthritis, Coronary Artery Disease, Hepatitis, Diabetes, Asthma
- Being tested
- HARP Intervention
- Medical subject headings
- Hypertension, Arthritis, Coronary Artery Disease, Hepatitis, Diabetes Mellitus, Asthma, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARP InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HARP Intervention | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
Secondary outcomes (3)
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).
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
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).
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
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.
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJun 2011
- Primary completion1 Jun 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Benjamin Druss, Emory University
- Investigators
- Benjamin Druss, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725815
- Sponsor's protocol ID
- IRB00047631a
- Other IDs
- 1R01MH090584-01A1
- Acronym
- HARP
- Status last verified
- Sep 2019
- First submitted
- 25 Apr 2012
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
- ClinicalTrials.gov ID
- NCT01725815
- Acronym / sponsor ID
- HARP / IRB00047631a
- Conditions
- Hypertension, Arthritis, Coronary Artery Disease, Hepatitis, Diabetes, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2011
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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),
Key exclusion criteria (1 listed)
- cognitive impairment based on a score of > 3 on a 6-item, validated screener developed for clinical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HARP InterventionThe 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. | Behavioural | HARP Intervention |
Primary outcome
Health Related Quality of Life (HRQOL)
Time frame: 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.
3 secondary outcomes
Behavioral Activation
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
Dietary Intake
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
Medication Adherence
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Druss, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARP Intervention in people with Hypertension and Arthritis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQOL) (time frame: Baseline, 3 months post-intervention, 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.