Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-01 @ 1:23 PM
Study NCT ID:
NCT00123357
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Health Related Quality of Life in Veterans With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-01', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2005-07-18', 'studyFirstSubmitQcDate': '2005-07-18', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Quality of Life', 'Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '19319761', 'type': 'RESULT', '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.'}, {'pmid': '14976324', 'type': 'RESULT', '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.'}, {'pmid': '15630787', 'type': 'RESULT', '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.'}, {'pmid': '15838417', 'type': 'RESULT', '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.'}, {'pmid': '12194620', 'type': 'RESULT', '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.'}, {'pmid': '16547774', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nApproximately 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.\n\nObjectives:\n\nThe 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?\n\nMethods:\n\nUsing 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.\n\nStatus:\n\nCompleted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo exclusion criteria.\n\nExclusion Criteria:\n\nNo exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00123357', 'briefTitle': 'Measuring Health Related Quality of Life in Veterans With Stroke', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Measuring Health Related Quality of Life in Veterans With Stroke', 'orgStudyIdInfo': {'id': 'STI 20-029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64128', 'city': 'Kansas', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kansas City VA Medical Center, Kansas City, MO', 'geoPoint': {'lat': 39.55281, 'lon': -87.93948}}], 'overallOfficials': [{'name': 'Dean M. Reker, PhD RN BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City VA Medical Center, Kansas City, MO'}, {'name': 'Pamela W. Duncan, PhD MA BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Florida/South Georgia Veterans Health System, Gainesville, FL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}