Cardiovascular DiseasePiezoRxNCT02837471
Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians
A study testing PiezoRx medical grade pedometer in people with Cardiovascular Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- PiezoRx medical grade pedometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Ottawa Heart Insititue
Ottawa, Ontario, K1Y 4W7
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
About this study
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)
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- PiezoRx medical grade pedometer
- Keywords
- Pedometer usability, Usability and feasibility, web application
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Secondary outcomes (13)
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.
Measured: 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
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.
Measured: One year
Validation of Physical activity questionnaire
Self-reported physical activity (in minutes/day) using the physical activity questionnaire.
Measured: One year
Validation of Physical activity questionnaire
Self-reported sitting time (in minutes/day) using the physical activity questionnaire.
Measured: One year
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.
Measured: 7 days
Changes in blood pressure
Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in blood lipids
Changes in total cholesterol, HDL, LDL, and Triglycerides (mmol/L) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in fasting glycosylated hemoglobin
Changes in fasting blood HbA1c (%) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body weight
Changes in body weight (kg) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body mass index
Changes in BMI (kg/m2) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in waist circumference
Changes in waist circumference (cm) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in resting heart rate
Changes in resting heart rate (bpm) from baseline to follow-ups
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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
Measured: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- StepsCount Inc
- Responsible party
- Principal investigator, Jennifer Reed, Ottawa Heart Institute Research Corporation
- Investigators
- Jennifer Reed, PhD MEd, CS, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837471
- Sponsor's protocol ID
- 20160491
- Acronym
- PiezoRx
- Status last verified
- Feb 2022
- First submitted
- 1 Jul 2016
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02837471
- Acronym / sponsor ID
- PiezoRx / 20160491
- Conditions
- Cardiovascular Disease
- Keywords
- Pedometer usability, Usability and feasibility, web application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- StepsCount Inc
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group, PiezoRx device | Experimental | Device: PiezoRx medical grade pedometerParticipants will use the PiezoRx pedometer at leisure for 12 weeks, and receive the standard care of the FrancoForme cardiac prevention and rehabilitation program. |
| Control group, Standard care | No intervention | –Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiezoRx medical grade pedometerParticipants 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 | Device | Intervention group, PiezoRx device |
Primary outcome
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.
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.
13 secondary outcomes
Changes in moderate to vigorous physical activity time
Time frame: 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
Validation of Physical activity questionnaire
Time frame: One year
Validation of Physical activity questionnaire
Time frame: One year
Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.
Time frame: 7 days
Changes in blood pressure
Time frame: 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 fasting glycosylated hemoglobin
Time frame: 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 mass index
Time frame: 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 resting heart rate
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Reed, PhD MEd, CS principal investigator
Ottawa Heart Institute Research Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiezoRx medical grade pedometer in people with Cardiovascular Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of participants who use the PiezoRx device (time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.