- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03095261
Incentives in Cardiac Rehabilitation
A Web-based Exercise Intervention With Financial Incentives for Cardiac Rehabilitation Graduates: A One Year Crossover Study Design
연구 개요
상태
정황
상세 설명
A 52-week, randomized, crossover study design will be employed to examine the impact of financial incentives on MVPA among cardiac rehabilitation (CR) program graduates. Two experimental therapies, (1) online self-monitoring plus 'virtual rewards' (i.e. badges) (ExTrack.ca) and (2) online self-monitoring plus 'financial incentives' (ExTracker.ca), will be administered for six months, one after the other.
Study participants will be randomly assigned (1:1) to receive these therapies in one of two orders: Group A will receive ExTrack.ca (virtual rewards) for six months, followed by ExTracker.ca (financial incentives) for the next six months; Group B will receive the financial incentive condition first, and the virtual rewards condition second. While exposed to the incentive condition, participants will be eligible to earn financial reward per day exercise is tracked.
This study design allows for the assessment of 'real world' uptake of an incentive program among CR patients, since both Groups A and B will be able to earn incentives. This design will also help determine if incentives sustain MVPA in the first six months post-CR compared with the virtual rewards condition. Finally, the crossover design will allow the exploration of incentive 'timing' - that is, figuring out if incentives more effectively sustain MVPA post-CR if they are offered immediately, versus six months after graduation when patient motivation tends to wane.
In addition to tracking exercise sessions using the online self-monitoring tool, participants will be asked to record steps per day, and 10-minute MVPA bouts per day, using a StepsCount accelerometer. To check the accuracy of participant entries, participants will be asked to mail-in their accelerometers at the study mid- and end-points (26 and 52 weeks, respectively). Participants will also be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3) at baseline (T1), study mid-point/crossover (T2), and study end-point (T3) as well as cardiopulmonary fitness assessments at T1 and T3.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Ontario
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Toronto, Ontario, 캐나다, M4G 2V6
- 모병
- Toronto Rehabilitation Insitute
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연락하다:
- Marc Mitchell, PhD
- 전화번호: 4166607881
- 이메일: marc.mitchell@uhn.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- CR program graduate (actively participating in program in month six, the final month, of the CR program).
Exclusion Criteria:
- No internet access
- Non-English speaking
- Diagnosed cognitive disorder
- Participating in another post-CR intervention study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Self-monitoring (financial incentives then virtual rewards)
Participants will be asked to track their exercise daily, using an online tool called ExTracker.ca,
for 52 weeks.
Date, type of exercise, time spent exercising, and distance covered will be self-reported, as will steps per day and 10-minute bouts of MVPA per day (measured by an accelerometer).
In the first six months, participants will earn financial incentive (ex.
grocery vouchers) each day exercise is tracked.
In the second six months, participants will earn virtual rewards (i.e.
heart badges) each day exercise is tracked.
|
All participants will have access to a web-based exercise tracking tool called ExTracker.
Individuals will be asked to submit their exercise diaries daily for 52 weeks, using the ExTracker program.
Upon entering exercise information, participants will receive individual (e.g., You've completed 50% of your exercise sessions this week!) and group-level (e.g., You and the other people in this study are walking across Canada!
Next stop - Toronto!) feedback.
Should participants cease to use the platform for one week, they will receive an email reminder to re-engage with the platform.
Three such emails will be sent to lapsing participants.
All participants will be asked to wear the StepsCount Piezo accelerometer, and track the steps per day and bout minutes of MVPA per day measured by the device.
Additionally, participants will be mailed an accelerometer (and asked to return their used ones) at study weeks 26 and 52 in order for the researcher to confirm the data inputted into the ExTracker from the device.
Participants will earn financial incentives each day they track their exercise, for the first six months of the study.
In the second six months, participants will "crossover" to the other therapy, the 'virtual rewards' therapy, for six months.
|
|
활성 비교기: Self-monitoring (virtual rewards then financial incentives)
Participants will be asked to track their exercise daily, using an online tool called ExTrack.ca, for 52 weeks.
Date, type of exercise, time spent exercising, and distance covered will be self-reported, as will steps per day and 10-minute bouts of MVPA per day (measured by an accelerometer).
In the first six months, participants will earn virtual rewards (i.e.
heart badges) each day exercise is tracked.
In the second six months, participants will earn financial incentive (ex.
grocery vouchers) each day exercise is tracked.
|
All participants will have access to a web-based exercise tracking tool called ExTracker.
Individuals will be asked to submit their exercise diaries daily for 52 weeks, using the ExTracker program.
Upon entering exercise information, participants will receive individual (e.g., You've completed 50% of your exercise sessions this week!) and group-level (e.g., You and the other people in this study are walking across Canada!
Next stop - Toronto!) feedback.
Should participants cease to use the platform for one week, they will receive an email reminder to re-engage with the platform.
Three such emails will be sent to lapsing participants.
All participants will be asked to wear the StepsCount Piezo accelerometer, and track the steps per day and bout minutes of MVPA per day measured by the device.
Additionally, participants will be mailed an accelerometer (and asked to return their used ones) at study weeks 26 and 52 in order for the researcher to confirm the data inputted into the ExTracker from the device.
Participants will earn 'virtual rewards' (i.e. a heart badge) each day they track their exercise, for the first six months of the study.
In the second six months, participants will "crossover" to the other therapy, the 'financial incentive' therapy, for six months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
기간: Baseline and 6 months
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The primary outcome of this trial will be minutes of objectively assessed MVPA per week measured by StepsCount Piezo accelerometers from baseline to 6 months.
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Baseline and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
기간: 6 months and12 months
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MVPA minutes per week from 6 months to 12 months will be a secondary outcome.
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6 months and12 months
|
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Change from baseline in Aerobic fitness at 12 months
기간: Baseline and12 months
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Aerobic fitness will be a secondary outcome as well, measured by symptom limited exercise stress test at baseline and 12 months, given its strong and graded (inverse) associations with cardiovascular disease-related outcomes.
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Baseline and12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Motivation at 6 months and 12 months
기간: Baseline, 6 months and12 months
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Participants will also be asked to complete a 23-item questionnaire designed to measure self-determined motivation to exercise (the BREQ-3) (Wilson et al. 2006) at Baseline, 6 months, and 12 months.
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Baseline, 6 months and12 months
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Enrolment
기간: 12 months
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Study recruitment rate will be calculated by dividing the number of consenting CR patients by the number of eligible CR graduates who were recruited to participate in the study.
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12 months
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Engagement
기간: 12 months
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Level of engagement will be defined as proportion of days ExTracker data submitted.
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paul Oh, MD, University Health Network, Toronto
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 15-9066
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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