Measuring Health Related Quality of Life in Veterans With Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00123357
First received: July 18, 2005
Last updated: October 25, 2013
Last verified: January 2005

July 18, 2005
October 25, 2013
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Complete list of historical versions of study NCT00123357 on ClinicalTrials.gov Archive Site
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Measuring Health Related Quality of Life in Veterans With Stroke
Measuring Health Related Quality of Life in Veterans With Stroke

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.

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.

Observational
Time Perspective: Prospective
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  • Stroke
  • Quality of Life
  • Rehabilitation
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Group 1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
March 2003
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Inclusion Criteria:

No exclusion criteria.

Exclusion Criteria:

No exclusion criteria.

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00123357
STI 20-029
No
Department of Veterans Affairs
Department of Veterans Affairs
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Principal Investigator: Dean M. Reker, PhD RN BS Edward Hines Jr. VA Hospital
Principal Investigator: Pamela W. Duncan, PhD MA BS Duke University
Department of Veterans Affairs
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP