- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
연구 개요
상세 설명
Stroke is a leading cause of disability in Canada and frequently causes hemiparesis (upper limb and lower limb weakness on one side of the body). Approximately one third of stroke survivors require physical rehabilitation to improve their motor and functional recovery (1). Although many strategies have been shown to be effective in promoting recovery after stroke, the uptake of evidence-based practice by rehabilitation professionals across Canada is variable. The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
This project is a cluster randomized implementation trial for upper and lower limb interventions. Rehabilitation centres across Canada will be randomized to receive either an outcome-oriented implementation strategy (OOI) to facilitate implementation of the EIPRs or a process-oriented implementation strategy (POI). At the onset, rehabilitation professionals practicing in all centres will receive education in using best practice outcome measures related to stroke rehabilitation. All centres will be assessed for baseline adherence to the EIPRs. Centres in the OOI will receive "usual care" (i.e. passive dissemination of the written protocols and information about outcome measures). Centres in the POI arm will receive a combination of strategies to facilitate EIPR uptake (i.e., use of a local facilitator, practice audits with feedback, reminder systems and educational sessions). Following exposure to the EIPRs, all centres will document adherence to the EIPRs, and patient outcomes as assessed by the measures. An analysis of the costs associated with rehabilitation interventions and the incremental expense of a POI strategy will be undertaken. These data will be used to compare the OOI and POI centres with respect to the level of uptake and implementation of EIPRs and related expenses.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Amanda G Hurdowar, MSc
- 전화번호: 7859 416-597-3422
- 이메일: Hurdowar.Amanda@TorontoRehab.on.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2A2
- 모병
- Toronto Rehabilitation Institute
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연락하다:
- Amanda Hurdowar, MSc
- 전화번호: 7859 416-597-3422
- 이메일: Hurdowar.Amanda@TorontoRehab.on.ca
-
수석 연구원:
- Mark T Bayley, MD
-
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Quebec
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Montreal, Quebec, 캐나다, H3G 1Y5
- 아직 모집하지 않음
- McGill University
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연락하다:
- Sharon Wood-Dauphinee, PhD
- 전화번호: (514) 398-5326
- 이메일: sharon.wood.dauphinee@mcgill.ca
-
수석 연구원:
- Sharon Wood-Dauphinee, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Rehabilitation Hospitals/Research Sites:
Inclusion Criteria:
- hospital with designated rehabilitation beds;
- regularly treats stroke patients;
- has access to at least one physical (PT) and one occupational (OT) therapist on the health professional team
Exclusion Criteria:
- Inadequate staffing to administer the outcome measures consistently
Patients:
Inclusion Criteria:
- medically stable;
- stroke with residual disability;
- requires complex rehabilitation interventions from at least 3 health care professionals, one of them being an OT or a PT;
- admitted to rehabilitation centre within 90 days of stroke onset;
- and age >18 years
Exclusion Criteria:
- having a medical condition that is expected to result in death within 6 months;
- presence of a serious chronic disabling condition that impacts on either the rehabilitation process or rehabilitation outcomes such as severe arthritis, dementia, Parkinson's disease;
- active suicidal ideation or symptoms of psychosis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Arm function as measured by the Box and Block test
|
Walking speed as measured by the 6 minutes walk test
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2차 결과 측정
결과 측정 |
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Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
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Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
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Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
|
Economic outcomes measured by the Quality Adjusted Life Years (QALY)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark T Bayley, MD, Toronto Rehabilitation Institute
- 수석 연구원: Sharon Wood-Dauphinee, PhD, McGill University
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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