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

Cardiovascular Disease Clinical Trial

— PiezoRx  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837471
• Other study ID #: 20160491
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Insititue	Ottawa	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	StepsCount Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of participants who use the PiezoRx device	The number of participants who use the device will be defined as the number of participants who create and use the online account during the trial.	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Primary	Change in frequency of using the PiezoRx device	The frequency of usage will be defined as the number of times the participants logon into the online account to upload the steps count and/or physical activity levels.	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in moderate to vigorous physical activity time	Changes in levels of moderate to vigorous physical activity (in minutes per week) from baseline to follow-ups will be measured by the PiezoRx device.	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention	The number of participants who continue wearing the PiezoRx device beyond the 3 month intervention will be defined as the number of participants who continue to use the online account.	One year
Secondary	Validation of Physical activity questionnaire	Self-reported physical activity (in minutes/day) using the physical activity questionnaire.	One year
Secondary	Validation of Physical activity questionnaire	Self-reported sitting time (in minutes/day) using the physical activity questionnaire.	One year
Secondary	Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.	Data recorded from PiezoRx device and ActiGraph accelerometer will be collected for 7days. Values will be compared to validate the PiezoRx device against the ActiGraph.	7 days
Secondary	Changes in blood pressure	Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in blood lipids	Changes in total cholesterol, HDL, LDL, and Triglycerides (mmol/L) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in fasting glycosylated hemoglobin	Changes in fasting blood HbA1c (%) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in body weight	Changes in body weight (kg) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in body mass index	Changes in BMI (kg/m2) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in waist circumference	Changes in waist circumference (cm) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in resting heart rate	Changes in resting heart rate (bpm) from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary	Changes in anxiety and depression	Changes in measures of anxiety and depression as assessed using the Hospital Anxiety and Depression Scale from baseline to follow-ups	One year (Baseline to 12 weeks, and baseline to 52 weeks)