Measuring Health Related Quality of Life in Veterans With Stroke
NCT ID: NCT00123357
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2003-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Group 1
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
No exclusion criteria.
Exclusion Criteria:
No exclusion criteria.
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Dean M. Reker, PhD RN BS
Role: PRINCIPAL_INVESTIGATOR
Kansas City VA Medical Center, Kansas City, MO
Pamela W. Duncan, PhD MA BS
Role: PRINCIPAL_INVESTIGATOR
North Florida/South Georgia Veterans Health System, Gainesville, FL
Locations
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Kansas City VA Medical Center, Kansas City, MO
Kansas, Illinois, United States
Countries
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References
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Hayes J, Vogel B, Reker DM. Factors associated with VHA costs of care for first 12 months after first stroke. J Rehabil Res Dev. 2008;45(9):1375-84.
Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability measures in stroke: relationship among the Barthel Index, the Functional Independence Measure, and the Modified Rankin Scale. Stroke. 2004 Apr;35(4):918-23. doi: 10.1161/01.STR.0000119385.56094.32. Epub 2004 Feb 19.
Jia H, Uphold CR, Wu S, Reid K, Findley K, Duncan PW. Health-related quality of life among men with HIV infection: effects of social support, coping, and depression. AIDS Patient Care STDS. 2004 Oct;18(10):594-603. doi: 10.1089/apc.2004.18.594.
Duncan P, Reker D, Kwon S, Lai SM, Studenski S, Perera S, Alfrey C, Marquez J. Measuring stroke impact with the stroke impact scale: telephone versus mail administration in veterans with stroke. Med Care. 2005 May;43(5):507-15. doi: 10.1097/01.mlr.0000160421.42858.de.
Duncan PW, Reker DM, Horner RD, Samsa GP, Hoenig H, LaClair BJ, Dudley TK. Performance of a mail-administered version of a stroke-specific outcome measure, the Stroke Impact Scale. Clin Rehabil. 2002 Aug;16(5):493-505. doi: 10.1191/0269215502cr510oa.
Kwon S, Duncan P, Studenski S, Perera S, Lai SM, Reker D. Measuring stroke impact with SIS: construct validity of SIS telephone administration. Qual Life Res. 2006 Apr;15(3):367-76. doi: 10.1007/s11136-005-2292-2.
Other Identifiers
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STI 20-029
Identifier Type: -
Identifier Source: org_study_id
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