Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123357
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-07-18
Brief Title:
Measuring Health Related Quality of Life in Veterans With Stroke
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Measuring Health Related Quality of Life in Veterans With Stroke
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 11000 veterans annually are hospitalized with a newly acquired incident stroke Based on American Heart Association ratios of stroke incidence and prevalence up to 80000 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 11000 veterans annually are hospitalized with a newly acquired incident stroke Based on American Heart Association ratios of stroke incidence and prevalence up to 80000 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
Approximately 11000 veterans annually are hospitalized with a newly acquired incident stroke Based on American Heart Association ratios of stroke incidence and prevalence up to 80000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None