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

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ClinicalTrials.gov Identifier: NCT02837471
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
StepsCount Inc
Information provided by (Responsible Party):
Jennifer Reed, Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Device: PiezoRx medical grade pedometer Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Validation of Physical activity questionnaire [ Time Frame: One year ]
    Self-reported physical activity (in minutes/day) using the physical activity questionnaire.

  4. Validation of Physical activity questionnaire [ Time Frame: One year ]
    Self-reported sitting time (in minutes/day) using the physical activity questionnaire.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837471


Contacts
Contact: Jennifer L Reed, PhD MEd, CS 6136967392 ext 67392 jreed@ottawaheart.ca
Contact: Christie Cole, MSc, BSc 613-696-7000 ext 14479 cacole@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Insititue Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
Contact: Christie Cole, MSc, BSc    6136967000 ext 14479    cacole@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
StepsCount Inc
Investigators
Principal Investigator: Jennifer Reed, PhD MEd, CS Ottawa Heart Institute Research Corporation

Responsible Party: Jennifer Reed, Associate Scientist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02837471     History of Changes
Other Study ID Numbers: 20160491
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Jennifer Reed, Ottawa Heart Institute Research Corporation:
Pedometer usability
Usability and feasibility
web application

Additional relevant MeSH terms:
Cardiovascular Diseases