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Measuring Health Related Quality of Life in Veterans With Stroke
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123357
  Purpose

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.


Condition
Stroke
Quality of Life
Rehabilitation

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Measuring Health Related Quality of Life in Veterans With Stroke

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 800
Study Completion Date: March 2003
Groups/Cohorts
1

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

No exclusion criteria.

Exclusion Criteria:

No exclusion criteria.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123357

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
Investigators
Principal Investigator: Dean M. Reker, PhD RN BS Edward Hines Jr. VA Hospital
  More Information

Publications of Results:
Nelson K, Garcia RE, Brown J, Mangione CM, Louis TA, Keeler E, Cretin S. Do patient consent procedures affect participation rates in health services research? Med Care. 2002 Apr;40(4):283-8.
McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA. 2003 Jul 16;290(3):360-6.
Feussner JR, Burris JF, McGlynn G, Lavori PW. Enhancing protections for human participants in clinical and health services research: a continuing process. Med Care. 2002 Sep;40(9 Suppl):V4-11.
Karlawish JH, Fox E, Pearlman R. How changes in health care practices, systems, and research challenge the practice of informed consent. Med Care. 2002 Sep;40(9 Suppl):V12-9.
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. 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.
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.
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.
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.

Responsible Party: Department of Veterans Affairs ( Reker, Dean - Principal Investigator )
Study ID Numbers: STI 20-029
Study First Received: July 18, 2005
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00123357  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Quality of Life
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009