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

February 8, 2022 updated by: Jennifer Reed, Ottawa Heart Institute Research Corporation

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Insititue
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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
No Intervention: Control group, Standard care
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in number of participants who use the PiezoRx device
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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)
Change in frequency of using the PiezoRx device
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in moderate to vigorous physical activity time
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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)
Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention
Time Frame: One year
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
Validation of Physical activity questionnaire
Time Frame: One year
Self-reported physical activity (in minutes/day) using the physical activity questionnaire.
One year
Validation of Physical activity questionnaire
Time Frame: One year
Self-reported sitting time (in minutes/day) using the physical activity questionnaire.
One year
Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.
Time Frame: 7 days
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
Changes in blood pressure
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in blood lipids
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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)
Changes in fasting glycosylated hemoglobin
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in fasting blood HbA1c (%) from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body weight
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body weight (kg) from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body mass index
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in BMI (kg/m2) from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in waist circumference
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in waist circumference (cm) from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in resting heart rate
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in resting heart rate (bpm) from baseline to follow-ups
One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in anxiety and depression
Time Frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Heart Institute Research Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
StepsCount Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Reed, PhD MEd, CS, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20160491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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