Incentives in Cardiac Rehabilitation

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Web-based exercise diary; Device: Accelerometer; Behavioral: Financial Incentive; Behavioral: Virtual Reward

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 2V6
      • Recruiting
      • Toronto Rehabilitation Insitute
      • Contact: Marc Mitchell, PhD; Phone Number: 4166607881; Email: marc.mitchell@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Web-based exercise diary; 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.; Device: Accelerometer; 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.; Behavioral: Financial Incentive; 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.
Active Comparator: 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.	Behavioral: Web-based exercise diary; 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.; Device: Accelerometer; 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.; Behavioral: Virtual Reward; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Motivation at 6 months and 12 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	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	Level of engagement will be defined as proportion of days ExTracker data submitted.	12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Paul Oh, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Cardiac Rehabilitation; Financial Incentives; Outpatient (Phase II) Cardiac Rehabilitation Exercise Adherence
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 15-9066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO