SchizophreniaNCT00169052
Health Care Management and Rehabilitation Skills Training for Treating Serious Mental Illness in Older People
A study testing Health Care Management and Supported Rehabilitation in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial summary
This study will evaluate the effectiveness of a health management and supported rehabilitation intervention in treating serious mental illnesses in older people. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Health Care Management and Supported Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2001to Aug 2006
- 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 50 years and older
- Women only
- Adult, Older adult
Who may be able to join
- age 50+ with schizophrenia,schizoaffective disorder,bipolar disorder, major depression with functional impairment
Who cannot join
- dementia, life threatening acute medical condition.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Freedom Trail Clinic
Boston, Massachusetts, 02114
Massachusetts Mental Health Center
Boston, Massachusetts, 02115
Community Council of Nashua
Nashua, New Hampshire, 03060
About this study
Official title: Rehabilitation and Health Care for Elderly With SMI
This study will evaluate the effectiveness of a health management and supported rehabilitation intervention in treating serious mental illnesses in older people.
Read the detailed description
This randomized, controlled study will evaluate the effectiveness of a health management (HM) and supported rehabilitation (SR) intervention for 180 older persons (age 50+) with serious mental illness. We will address the following specific aims and hypotheses:
Specific Aim 1- To compare the effectiveness of SR/HM to UC in improving independent living skills and health management. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will have better independent living skills and health management, evidenced by:
- Better community living skills and better social skills based on performance-based measures and self-reports of functioning, and
- Better medication management skills based on performance-based and self-report measures and greater use of preventive and routine primary health care (including annual check-ups with a primary care provider and participation in preventive health care).
Specific Aim 2- To compare the effectiveness of SR/HM to UC in decreasing the use of high-cost acute and long-term institution-based services. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will use fewer high cost services, including emergency room visits, acute hospitalizations, and nursing home care. In addition, the reduced use of high cost institution-based services will be associated with better independent living skills and health management practices resulting from the SR/HM intervention.
We will also evaluate the following secondary, exploratory hypotheses:
- The SR/HM intervention will be associated with better general health status.
- The effectiveness of SR/HM in improving living skills and community functioning will be greatest for individuals with low levels of cognitive impairment.
In addition, we will describe outpatient service utilization for SR/HM and UC models within each study site in order to present a more comprehensive account of services used by study participants.
Little is known about how to provide effective rehabilitation and health management services to older persons with serious mental illness (SMI) to decrease the use of high-cost institution-based services. To address this need, we developed a supported rehabilitation and health management (SR/HM) intervention for older persons with SMI that addresses functioning in two areas essential for preventing hospitalizations and long-term institutional care: (1) enhanced independent living skills and (2) improved health management. The supported rehabilitation (SR) component consists of skills training aimed at improving competence in everyday functioning, including community living skills and social skills. The health management (HM) component consists of training in health management skills and health case management by nurses who monitor and facilitate routine preventive and acute health care. Results from a pilot study indicate that SR/HM is effective in improving independent living skills and health management for older persons with SMI.
The aims of this study are to test the effectiveness of the SR/HM intervention in improving the functioning and health care of older persons with SMI and in reducing the use of high cost, acute and long-term institution-based care. The proposed research will compare the SR/HM intervention to usual care (UC) in a randomized, controlled study of 180 individuals age 60 and older with SMI living in the community.
- Being tested
- Health Care Management and Supported Rehabilitation
- Keywords
- geriatric,, older, serious mental illness, SMI
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Care Management and Supported RehabilitationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
independent living, social and health behavior skills
preventive health care
Secondary outcomes (1)
Acute emergency, hospitalization and long-term institution-based care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2001
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Single group
- Masking
- Single blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Stephen J Bartels, MD, Principal investigator, Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169052
- Sponsor's protocol ID
- R01MH062324
- Other IDs
- R01MH062324, DSIR 82-SEMS
- Status last verified
- Sep 2001
- First submitted
- 11 Sep 2005
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Health Care for Elderly With SMI
- ClinicalTrials.gov ID
- NCT00169052
- Acronym / sponsor ID
- R01MH062324
- Keywords
- geriatric,, older, serious mental illness, SMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Study completion
- Aug 2006
- First posted
- 15 Sep 2005 (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 health management and supported rehabilitation intervention in treating serious mental illnesses in older people.
Detailed description
This randomized, controlled study will evaluate the effectiveness of a health management (HM) and supported rehabilitation (SR) intervention for 180 older persons (age 50+) with serious mental illness. We will address the following specific aims and hypotheses:
Specific Aim 1- To compare the effectiveness of SR/HM to UC in improving independent living skills and health management. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will have better independent living skills and health management, evidenced by:
- Better community living skills and better social skills based on performance-based measures and self-reports of functioning, and
- Better medication management skills based on performance-based and self-report measures and greater use of preventive and routine primary health care (including annual check-ups with a primary care provider and participation in preventive health care).
Specific Aim 2- To compare the effectiveness of SR/HM to UC in decreasing the use of high-cost acute and long-term institution-based services. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will use fewer high cost services, including emergency room visits, acute hospitalizations, and nursing home care. In addition, the reduced use of high cost institution-based services will be associated with better independent living skills and health management practices resulting from the SR/HM intervention.
We will also evaluate the following secondary, exploratory hypotheses:
- The SR/HM intervention will be associated with better general health status.
- The effectiveness of SR/HM in improving living skills and community functioning will be greatest for individuals with low levels of cognitive impairment.
In addition, we will describe outpatient service utilization for SR/HM and UC models within each study site in order to present a more comprehensive account of services used by study participants.
Little is known about how to provide effective rehabilitation and health management services to older persons with serious mental illness (SMI) to decrease the use of high-cost institution-based services. To address this need, we developed a supported rehabilitation and health management (SR/HM) intervention for older persons with SMI that addresses functioning in two areas essential for preventing hospitalizations and long-term institutional care: (1) enhanced independent living skills and (2) improved health management. The supported rehabilitation (SR) component consists of skills training aimed at improving competence in everyday functioning, including community living skills and social skills. The health management (HM) component consists of training in health management skills and health case management by nurses who monitor and facilitate routine preventive and acute health care. Results from a pilot study indicate that SR/HM is effective in improving independent living skills and health management for older persons with SMI.
The aims of this study are to test the effectiveness of the SR/HM intervention in improving the functioning and health care of older persons with SMI and in reducing the use of high cost, acute and long-term institution-based care. The proposed research will compare the SR/HM intervention to usual care (UC) in a randomized, controlled study of 180 individuals age 60 and older with SMI living in the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 50+ with schizophrenia,schizoaffective disorder,bipolar disorder, major depression with functional impairment
Key exclusion criteria (1 listed)
- dementia, life threatening acute medical condition.
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 |
|---|---|---|
| Health Care Management and Supported Rehabilitation | Behavioural | – |
Primary outcome
independent living, social and health behavior skills
preventive health care
1 secondary outcome
Acute emergency, hospitalization and long-term institution-based care
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 10 Sep 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.
Stephen J Bartels, MD principal investigator
Dartmouth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Care Management and Supported Rehabilitation in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 3 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 1 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 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
independent living, social and health behavior skills. The study lists 2 primary outcomes in all. 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 10 Sep 2013.