StrokeNCT00123357
Measuring Health Related Quality of Life in Veterans With Stroke
An observational study of Stroke and Quality of Life, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Quality of Life, Rehabilitation
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No exclusion criteria.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City VA Medical Center, Kansas City, MO
Kansas, Illinois, 64128
About this study
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.
Read the 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.
- Conditions
- Stroke, Quality of Life, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dean M. Reker, PhD RN BS, Principal investigator, Kansas City VA Medical Center, Kansas City, MOPamela W. Duncan, PhD MA BS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123357
- Sponsor's protocol ID
- STI 20-029
- Status last verified
- Jan 2005
- First submitted
- 18 Jul 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19319761Kwon 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.
PubMed 14976324Jia 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.
PubMed 15630787Duncan 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.
PubMed 15838417Duncan 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.
PubMed 12194620Kwon 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.
PubMed 16547774
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Health Related Quality of Life in Veterans With Stroke
- ClinicalTrials.gov ID
- NCT00123357
- Acronym / sponsor ID
- STI 20-029
- Conditions
- Stroke, Quality of Life, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Mar 2003 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- No exclusion criteria.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 19319761Hayes 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.
- Results publication: PubMed 14976324Kwon 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.
- Results publication: PubMed 15630787Jia 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.
- Results publication: PubMed 15838417Duncan 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.
- Results publication: PubMed 12194620Duncan 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.
- Results publication: PubMed 16547774Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean M. Reker, PhD RN BS principal investigator
Kansas City VA Medical Center, Kansas City, MO
Pamela W. Duncan, PhD MA BS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Quality of Life, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123357, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.