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
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Measuring Health Related Quality of Life in Veterans With Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 800
Study Completion Date: March 2003

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

Sponsors and Collaborators
Investigators
Principal Investigator: Dean M. Reker, PhD RN BS Edward Hines Jr. VA Hospital
Principal Investigator: Pamela W. Duncan, PhD MA BS Duke University
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123357     History of Changes
Other Study ID Numbers: STI 20-029
Study First Received: July 18, 2005
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 14, 2014