Chronic DiseaseNCT00380536
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
A study testing Peer-Led Health Education Class in people with Chronic Disease and Mental Illness, run by Emory University at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Mental Illness
- What is being tested?
- Peer-Led Health Education Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Currently receiving treatment at Dekalb Community Service Board
- Chronic disease
Who cannot join
- History of more than two psychiatric or medical hospitalizations within the year prior to study entry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Winn Way Mental Health Center
Decatur, Georgia, 30030
Clifton Springs Mental Health Center
Decatur, Georgia, 30034
About this study
Official title: Adapting a Medical Self-Management Program for a Community Mental Health Center
This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.
Read the detailed description
People with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. Peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. This type of intervention, however, has yet to be systematically tested in individuals with mental disorders. Community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center.
Participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. Participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. Participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
- Conditions
- Chronic Disease, Mental Illness
- Being tested
- Peer-Led Health Education Class
- Keywords
- Peer-led Education
- Medical subject headings
- Chronic Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Led Health Education ClassBehavioural
Participants will participate in group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will participate in peer-led medical illness self-management group sessions. Receives: Behavioral: Peer-Led Health Education Class |
| 2 | No intervention | Participants will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient activation
Measured: Measured at Months 6 and 12
Secondary outcomes (1)
Health-related quality of life
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- None (open label)
- Enrolment
- 111 participants (estimated)
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
- NCT00380536
- Sponsor's protocol ID
- IRB00047631
- Other IDs
- R34MH078583, DAHBR 96-BHB
- Status last verified
- Nov 2013
- First submitted
- 22 Sep 2006
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Medical Self-Management Program for a Community Mental Health Center
- ClinicalTrials.gov ID
- NCT00380536
- Acronym / sponsor ID
- IRB00047631
- Conditions
- Chronic Disease, Mental Illness
- Keywords
- Peer-led Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.
Detailed description
People with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. Peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. This type of intervention, however, has yet to be systematically tested in individuals with mental disorders. Community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center.
Participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. Participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. Participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Peer-Led Health Education ClassParticipants will participate in peer-led medical illness self-management group sessions. |
| 2 | No intervention | –Participants will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently receiving treatment at Dekalb Community Service Board
- Chronic disease
Key exclusion criteria (1 listed)
- History of more than two psychiatric or medical hospitalizations within the year prior to study entry
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 |
|---|---|---|
| Peer-Led Health Education ClassParticipants will participate in group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system. | Behavioural | 1 |
Primary outcome
Patient activation
Time frame: Measured at Months 6 and 12
1 secondary outcome
Health-related quality of life
Time frame: Measured at Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Led Health Education Class in people with Chronic Disease and Mental Illness, run by Emory University at 2 sites 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 2 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient activation (time frame: Measured at Months 6 and 12). 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 19 Nov 2013.