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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | August 6, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012714 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Subacute Rehabilitative Care | ||||
| Official Title ICMJE | Evaluation of Subacute Rehabilitative Care | ||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Rehabilitative Services | ||||
| Intervention ICMJE | Behavioral: Case management services | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 180 | ||||
| Completion Date | June 2000 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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: |
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012714 | ||||
| Responsible Party | Evans, Ronald - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 94-125 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | March 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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