- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012714
Evaluation of Subacute Rehabilitative Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated rehabilitation effects only in isolated subgroups, b) focused on functional ability rather than on quality of life, c) not used randomized control groups, and d) had inadequate sample sizes. Differences in methodological approaches have resulted in inconsistent findings. The lack of long-term benefits suggests that services may need to be continued at home or in subacute care settings to optimize their effectiveness. Unfortunately, prior research did not include behavioral outcomes. The potential benefits of rehabilitative care could thus not be evaluated by these studies in more meaningful detail, and they did not accurately reflect the psychosocial objectives of rehabilitation.
Objectives:
The goal of this study was to measure the additive effect of outpatient, subacute rehabilitation as follow-up services to acute, inpatient rehabilitation on adults diagnosed with a disabling disorder in four major diagnostic groups (nervous, circulatory, musculoskeletal, and injury).
Methods:
A randomized clinical trial was conducted to determine the effects of subacute rehabilitative care on: 1) physical function, 2) health and mental health, 3) mortality, 4) family function, 5) personal adjustment, and 6) use of health care resources. Patients hospitalized for the first time with a disabling condition [n=180] were provided inpatient rehabilitation and then randomly assigned to either subacute rehabilitation at home [n=90] or to usual outpatient follow-up [n=90] in which only medical services were provided but no scheduled rehabilitative therapies were offered. To compare the two groups, analysis of covariance was conducted for the outcome variables. The between subjects factor was subacute rehabilitative care versus usual medical services as an outpatient.
Status:
Complete.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Presence of physical limitation and need for rehabilitative care as indicated by a score >1 (not independent) on the Nursing Ward Classification index; availability of a family member selected by the patient; Major Diagnostic Code (MDC) 1, 5, 8, or 21 (comprising 87% of cases)
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald L. Evans, MSW, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publications and helpful links
General Publications
- Evans RL, Connis RT, Haselkorn JK. Hospital-based rehabilitative care versus outpatient services: effect on functioning and health status. Disabil Rehabil. 1998 Aug;20(8):298-307. doi: 10.3109/09638289809166085.
- Evans RL. Perceived functional health of disabled elderly persons in a follow-up program for primary care. Psychol Rep. 1999 Apr;84(2):553-7. doi: 10.2466/pr0.1999.84.2.553.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IIR 94-125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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