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Incentives in Cardiac Rehabilitation

23. mars 2017 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

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Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M4G 2V6
        • Rekruttering
        • Toronto Rehabilitation Insitute
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in Motivation at 6 months and 12 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
Level of engagement will be defined as proportion of days ExTracker data submitted.
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Paul Oh, MD, University Health Network, Toronto

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2016

Primær fullføring (Forventet)

1. april 2018

Studiet fullført (Forventet)

1. april 2018

Datoer for studieregistrering

Først innsendt

13. oktober 2016

Først innsendt som oppfylte QC-kriteriene

23. mars 2017

Først lagt ut (Faktiske)

29. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

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NEI

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