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NCT00012714 Clinical Trial

Evaluation of Subacute Rehabilitative Care

Rehabilitative Services Clinical Trial

Official title:
Evaluation of Subacute Rehabilitative Care

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00012714
Other study ID # IIR 94-125
Secondary ID
Status Completed
Phase Phase 2
First received March 14, 2001
Last updated April 6, 2015
Est. completion date June 2000

Study information
Verified date February 2007
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date June 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Case management services

Locations
Country Name City State
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation