- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02754271
Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
연구 개요
상세 설명
The study introduces a highly accessible and compelling educational film designed to introduce, motivate, and sustain patient exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrology staff and family caregivers. Fit for Dialysis is a filmed drama that is based on focus group research with older hemodialysis patients, family caregivers, and health care practitioners that highlighted patients' desire to exercise as well as discouragement of patients to do so by overprotective families, and nurses' preferences for patient sedentariness during hemodialysis. Fit for Dialysis was tailored to the exigencies of out-patient hemodialysis settings by acknowledging and providing a roadmap to overcome the disciplinary silos and paternalism towards patients which inhibit exercise during hemodialysis, and highlighting some of the life circumstances that may influence patients' self-management of exercise behaviours at home and in the community.
In order to advance our understanding of the ways in which Fit for Dialysis influences participant outcomes, a prospective 2-site parallel intervention trial will be implemented that will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Each hospital will have a 12-week follow-up. Qualitative and quantitative methods will be used including semi-structured interviews, and physical fitness and activity measures. These data will be used to explore the impact of Fit for Dialysis on: the knowledge/attitudes of patients, family caregivers, and staff regarding exercise-based principles of wellness; the education, motivation, or maintenance of patient exercise during dialysis, at home, and in the community; adherence to exercise prescription; and patient physical fitness and activity outcomes. The study will also explore factors related to family caregivers, nephrologists, nurses, and hospital administrators, and patients' home and community environments that may impact the successful uptake of the key messages of Fit for Dialysis.
In the intervention site (film+exercise hospital), 30 patients will view Fit for Dialysis and participate in the exercise program; at the exercise-only hospital, 30 patients will only exercise. A family caregiver of each participating patient will either view Fit for Dialysis and read an information letter on the benefits and contraindications of exercise (in the film+exercise hospital), or will only read the information letter (in the exercise-only hospital). In the film+exercise hospital, five nephrologists, 10 nurses and 3 administrators will also view the film. In both hospitals, 10 patients, 10 family caregivers, 10 nurses, 5 nephrologists, 3 administrators, and the physiotherapist assistants will be interviewed.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M3M 0B2
- 모병
- Humber River Hospital - Wilson Site
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Toronto, Ontario, 캐나다, M8Z 6A4
- 모집하지 않고 적극적으로
- St. Joseph's Health Centre - Satellite Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have conversational ability in English
- Have a medical diagnosis of hemodialysis-dependent end-stage renal disease
- Are a registered hemodialysis patient in the hospital for at least 3 months
- Receive ≥ 2 in-centre hemodialysis sessions per week
- Are ambulatory (with or without aids)
- Are deemed medically eligible by their nephrologist to participate in an exercise program that includes stretching, strengthening, and cardiovascular components
- Have a family caregiver who agrees to participate in the exercise program and keep a log of exercises on non-dialysis days
Exclusion Criteria:
- Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
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A 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community.
|
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간섭 없음: Control
The 16-week exercise program involving activities during dialysis, at home, and in the community.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
기간: 1-16 weeks
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1-16 weeks
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Change in functional exercise capacity measured by the 2-Minute Walk Test
기간: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in number of steps using a pedometer
기간: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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Change in basic mobility using the Timed Up and Go
기간: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
|
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Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
기간: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
기간: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
기간: 1-16, 28 weeks
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1-16, 28 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pia Kontos, PhD, University Health Network, Toronto
간행물 및 유용한 링크
일반 간행물
- Kontos P, Grigorovich A, Colobong R, Miller KL, Nesrallah GE, Binns MA, Alibhai SMH, Parsons T, Jassal SV, Thomas A, Naglie G. Fit for Dialysis: a qualitative exploration of the impact of a research-based film for the promotion of exercise in hemodialysis. BMC Nephrol. 2018 Aug 6;19(1):195. doi: 10.1186/s12882-018-0984-4.
- Kontos P, Alibhai SM, Miller KL, Brooks D, Colobong R, Parsons T, Jassal SV, Thomas A, Binns M, Naglie G. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients. BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Fit for Dialysis에 대한 임상 시험
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Forendo Pharma LtdRichmond Pharmacology Limited완전한
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Oregon Health and Science University완전한근위축성 측삭 경화증 | 근이영양증 | 척수 손상 | 다계통 위축 | 파킨슨병과 파킨슨증 | 뇌종양 성인 | 감금 증후군 | 뇌간 뇌졸중미국
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University Hospital, BrestRegistre des Tumeurs Digestives du Finistère; Centre Régional de Coordination des Dépistages...완전한여성 | 대장내시경 | 신비로운 피 | 대량 스크리닝 | 암의 조기 발견 | 악성 대장 신생물 | 중년의프랑스
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
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SEFA HAKTAN HATIK아직 모집하지 않음혈압 | 건강한 자원봉사자 | 호흡 | 미주 신경 자극 | 자율 신경계 | 심박수터키 (Türkiye)
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National Taiwan University HospitalMinistry of Health and Welfare, Taiwan완전한
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Universidad Miguel Hernandez de Elche모집하지 않고 적극적으로
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Forendo Pharma LtdRichmond Pharmacology Limited완전한