Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this prospective randomized controlled trial (RCT) is to evaluate the feasibility and usability of a commercial pedometer and web application in a case-managed home-based Cardiovascular disease prevention and rehabilitation program for French-speaking Canadians.

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Detailed Description

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A cardiovascular disease (CVD) prevention and rehabilitation program is an evidence-based, standard of care for those who have coronary artery disease or other cardiac conditions; the aim of CVD prevention and rehabilitation program is to minimize disease progression and prevent future cardiovascular events. Behaviour change interventions targeting exercise are effective for improving physical activity levels, but can be intensive and costly. Activity monitors with accompanying web applications may provide a practical compliment to behaviour change interventions as an affordable way to promote and sustain increased physical activity levels, as measured by steps and physical activity levels. To date, no studies have examined the role of a pedometer with accompanying web application on steps and physical activity levels in French-speaking Canadians attending the FrancoForme® cardiac prevention and rehabilitation program at the University of Ottawa Heart Institute. It is also unknown the average daily steps of Canadian Francophone patients. Identifying successful interventions that promote physical activity among CVD prevention and rehabilitation program patients will help to improve their health as well as decrease the risk of first or subsequent cardiovascular events.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Intervention group, PiezoRx device

Participants will use the PiezoRx pedometer at leisure for 12 weeks, and receive the standard care of the FrancoForme cardiac prevention and rehabilitation program.

Group Type EXPERIMENTAL

PiezoRx medical grade pedometer

Intervention Type DEVICE

Participants will be asked to freely use the PiezoRx medical grade pedometer for 12 weeks.

Participants have access to a personal account created online and can record the daily steps count and physical activity.

Participants will receive the standard care by the FrancoForme Cardiovascular rehabilitation and prevention program

Control group, Standard care

Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PiezoRx medical grade pedometer

Participants will be asked to freely use the PiezoRx medical grade pedometer for 12 weeks.

Participants have access to a personal account created online and can record the daily steps count and physical activity.

Participants will receive the standard care by the FrancoForme Cardiovascular rehabilitation and prevention program

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Francophone (i.e., French-speaking);
* ≥18 years;
* Existing atherosclerotic vascular disease or ≥1 risk factor for CVD (e.g., family history of premature CVD, age \[sex dependent\], smoking, sedentary lifestyle, diabetes, hypertension, hypercholesterolemia, overweight/obesity);
* Live in the Champlain Region and attending the onsite FrancoForme® intake;
* Have a family physician or nurse practitioner (to order blood tests and titrate medications);
* Patient agrees to sign informed consent.

Exclusion Criteria

* Unwilling to wear activity monitors;
* Unable to engage in physical activity;
* Does not have access to the internet;
* Unable to attend follow-up visits;
* Unable to provide written, informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes