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Incentives in Cardiac Rehabilitation

2017年3月23日 更新者:Paul Oh、University Health Network, Toronto

A Web-based Exercise Intervention With Financial Incentives for Cardiac Rehabilitation Graduates: A One Year Crossover Study Design

The objective of this study is to examine whether a financial incentive program increases minutes of moderate-to-vigorous physical activity (MVPA) per week among cardiac rehabilitation (CR) graduates.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4G 2V6
        • 募集
        • Toronto Rehabilitation Insitute
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
時間枠:Baseline and 6 months
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.
Baseline and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
時間枠:6 months and12 months
MVPA minutes per week from 6 months to 12 months will be a secondary outcome.
6 months and12 months
Change from baseline in Aerobic fitness at 12 months
時間枠:Baseline and12 months
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.
Baseline and12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Change from baseline in Motivation at 6 months and 12 months
時間枠:Baseline, 6 months and12 months
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.
Baseline, 6 months and12 months
Enrolment
時間枠:12 months
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.
12 months
Engagement
時間枠:12 months
Level of engagement will be defined as proportion of days ExTracker data submitted.
12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Paul Oh, MD、University Health Network, Toronto

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年9月1日

一次修了 (予想される)

2018年4月1日

研究の完了 (予想される)

2018年4月1日

試験登録日

最初に提出

2016年10月13日

QC基準を満たした最初の提出物

2017年3月23日

最初の投稿 (実際)

2017年3月29日

学習記録の更新

投稿された最後の更新 (実際)

2017年3月29日

QC基準を満たした最後の更新が送信されました

2017年3月23日

最終確認日

2017年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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