NCT03095261

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

October 13, 2016

Last Update Submit

March 23, 2017

Conditions

Keywords

Cardiovascular DiseaseCardiac RehabilitationFinancial IncentivesOutpatient (Phase II) Cardiac Rehabilitation Exercise Adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months

    6 months and12 months

  • Change from baseline in Aerobic fitness at 12 months

    Baseline and12 months

Other Outcomes (3)

  • Change from baseline in Motivation at 6 months and 12 months

    Baseline, 6 months and12 months

  • Enrolment

    12 months

  • Engagement

    12 months

Study Arms (2)

Self-monitoring (financial incentives then virtual rewards)

EXPERIMENTAL

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 diaryDevice: AccelerometerBehavioral: Financial Incentive

Self-monitoring (virtual rewards then financial incentives)

ACTIVE COMPARATOR

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 diaryDevice: AccelerometerBehavioral: Virtual Reward

Interventions

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.

Self-monitoring (financial incentives then virtual rewards)Self-monitoring (virtual rewards then financial incentives)

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.

Self-monitoring (financial incentives then virtual rewards)Self-monitoring (virtual rewards then financial incentives)
Virtual RewardBEHAVIORAL

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.

Self-monitoring (virtual rewards then financial incentives)

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.

Self-monitoring (financial incentives then virtual rewards)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CR program graduate (actively participating in program in month six, the final month, of the CR program).

You may not qualify if:

  • No internet access
  • Non-English speaking
  • Diagnosed cognitive disorder
  • Participating in another post-CR intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Insitute

Toronto, Ontario, M4G 2V6, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Paul Oh, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Mitchell, PhD

CONTACT

Golnoush Taherzadeh, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of the Cardiovascular Prevention and Rehabilitation Program

Study Record Dates

First Submitted

October 13, 2016

First Posted

March 29, 2017

Study Start

September 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations