Clinical trial NCT02837471: Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians
Official title: Assessing the Feasibility and Usability of a Commercial Medical Grade Pedometer in a Case-managed Home-based Primary and Secondary Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx RCT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Pedometer usability
Usability and feasibility
web application
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: StepsCount Inc
First posted: 2016-07-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of participants who use the PiezoRx device
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Change in frequency of using the PiezoRx device
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary outcomes:
measure: Changes in moderate to vigorous physical activity time
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention
timeFrame: One year
measure: Validation of Physical activity questionnaire
timeFrame: One year
measure: Validation of Physical activity questionnaire
timeFrame: One year
measure: Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.
timeFrame: 7 days
measure: Changes in blood pressure
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in blood lipids
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in fasting glycosylated hemoglobin
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in body weight
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in body mass index
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in waist circumference
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in resting heart rate
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
measure: Changes in anxiety and depression
timeFrame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insititue
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer Reed, PhD MEd, CS
role: PRINCIPAL_INVESTIGATOR
References: