NCT02837471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

July 1, 2016

Last Update Submit

February 8, 2022

Conditions

Cardiovascular Disease

Keywords

Pedometer usabilityUsability and feasibilityweb application

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (13)

  • Changes in moderate to vigorous physical activity time

    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

    One year

  • Validation of Physical activity questionnaire

    One year

  • Validation of Physical activity questionnaire

    One year

  • Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.

    7 days

  • +8 more secondary outcomes

Study Arms (2)

Intervention group, PiezoRx device

EXPERIMENTAL

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

Control group, Standard care

NO INTERVENTION

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

Interventions

PiezoRx medical grade pedometerDEVICE

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 group, PiezoRx device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jennifer Reed, PhD MEd, CS

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 19, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Locations

CA(2)