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Clinical Trials/NCT00123357
NCT00123357
Completed
N/A

Measuring Health Related Quality of Life in Veterans With Stroke

US Department of Veterans Affairs1 site in 1 country800 target enrollmentJuly 22, 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
US Department of Veterans Affairs
Enrollment
800
Locations
1
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life.

Detailed Description

Background: Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life. Objectives: The major research questions in this investigation are: 1) Does the SIS have concurrent and discriminate validity in a veteran stroke population when compared to the FIM, Rankin, and the SF-36V? 2) What effect does mode of administration have on response rates, bias, data quality, reliability and validity, SIS domain scores, and cost of data collection? 3) What factors differentiate responders and non-responders? 4) Will the SIS scores predict health care costs and utilization? Methods: Using ICD-9 discharge codes and electronic medical records, patients were screened for a valid diagnosis of stroke. At three months post-stroke, patients were randomly assigned to receive a mailed SIS instrument or SIS via telephone interview. At four months post-stroke, all respondents were evaluated using the Functional Independence Measure and SF-36V by telephone. Status: Completed.

Registry
clinicaltrials.gov
Start Date
July 22, 2005
End Date
March 2003
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • No exclusion criteria.

Exclusion Criteria

  • No exclusion criteria.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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