Clinical trial NCT00123357: Measuring Health Related Quality of Life in Veterans With Stroke
Official title: Measuring Health Related Quality of Life in Veterans With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Quality of Life
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-22
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

Eligibility criteria: Inclusion Criteria:

No exclusion criteria.

Exclusion Criteria:

No exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City VA Medical Center, Kansas City, MO
state: Illinois
Study officials:
affiliation: Kansas City VA Medical Center, Kansas City, MO
name: Dean M. Reker, PhD RN BS
role: PRINCIPAL_INVESTIGATOR
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Pamela W. Duncan, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.