Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Incentives in Cardiac Rehabilitation

23 mars 2017 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ontario
      • Toronto, Ontario, Canada, M4G 2V6
        • Recrutement
        • Toronto Rehabilitation Insitute
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Motivation at 6 months and 12 months
Délai: 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
Délai: 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
Délai: 12 months
Level of engagement will be defined as proportion of days ExTracker data submitted.
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Paul Oh, MD, University Health Network, Toronto

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2016

Achèvement primaire (Anticipé)

1 avril 2018

Achèvement de l'étude (Anticipé)

1 avril 2018

Dates d'inscription aux études

Première soumission

13 octobre 2016

Première soumission répondant aux critères de contrôle qualité

23 mars 2017

Première publication (Réel)

29 mars 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mars 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 15-9066

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner