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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00169052
Other study ID # R01MH062324
Secondary ID R01MH062324DSIR
Status Completed
Phase N/A
First received September 11, 2005
Last updated September 6, 2013
Start date September 2001
Est. completion date August 2006

Study information

Verified date September 2001
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of a health management and supported rehabilitation intervention in treating serious mental illnesses in older people.


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:

1. Better community living skills and better social skills based on performance-based measures and self-reports of functioning, and

2. 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:

1. The SR/HM intervention will be associated with better general health status.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria:

- age 50+ with schizophrenia,schizoaffective disorder,bipolar disorder, major depression with functional impairment

Exclusion Criteria:

- dementia, life threatening acute medical condition.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Behavioral:
Health Care Management and Supported Rehabilitation


Locations

Country Name City State
United States Freedom Trail Clinic Boston Massachusetts
United States Massachusetts Mental Health Center Boston Massachusetts
United States Community Council of Nashua Nashua New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary independent living, social and health behavior skills
Primary preventive health care
Secondary Acute emergency, hospitalization and long-term institution-based care
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