Clinical trial NCT03095261: Incentives in Cardiac Rehabilitation
Official title: A Web-based Exercise Intervention With Financial Incentives for Cardiac Rehabilitation Graduates: A One Year Crossover Study Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular Disease
Cardiac Rehabilitation
Financial Incentives
Outpatient (Phase II) Cardiac Rehabilitation Exercise Adherence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
timeFrame: 6 months and12 months
measure: Change from baseline in Aerobic fitness at 12 months
timeFrame: Baseline and12 months
Other outcomes:
measure: Change from baseline in Motivation at 6 months and 12 months
timeFrame: Baseline, 6 months and12 months
measure: Enrolment
timeFrame: 12 months
measure: Engagement
timeFrame: 12 months
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Insitute
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Paul Oh, MD
role: PRINCIPAL_INVESTIGATOR
References: