Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx)
8. februar 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
54
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Insititue
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Ottawa, Ontario, Canada, K1Y4W7
- University of Ottawa Heart Institute
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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 |
|
Ingen indgriben: Control group, Standard care
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in number of participants who use the PiezoRx device
Tidsramme: 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
Tidsramme: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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.
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in moderate to vigorous physical activity time
Tidsramme: 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.
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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
Tidsramme: 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.
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One year
|
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Validation of Physical activity questionnaire
Tidsramme: One year
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Self-reported physical activity (in minutes/day) using the physical activity questionnaire.
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One year
|
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Validation of Physical activity questionnaire
Tidsramme: One year
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Self-reported sitting time (in minutes/day) using the physical activity questionnaire.
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One year
|
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Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.
Tidsramme: 7 days
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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.
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7 days
|
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Changes in blood pressure
Tidsramme: One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in blood lipids
Tidsramme: 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
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in fasting glycosylated hemoglobin
Tidsramme: 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
Tidsramme: 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)
|
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Changes in body mass index
Tidsramme: 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
Tidsramme: One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
Changes in waist circumference (cm) from baseline to follow-ups
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in resting heart rate
Tidsramme: One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
Changes in resting heart rate (bpm) from baseline to follow-ups
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in anxiety and depression
Tidsramme: 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)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennifer Reed, PhD MEd, CS, Ottawa Heart Institute Research Corporation
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2016
Primær færdiggørelse (Faktiske)
1. december 2019
Studieafslutning (Faktiske)
1. december 2019
Datoer for studieregistrering
Først indsendt
1. juli 2016
Først indsendt, der opfyldte QC-kriterier
14. juli 2016
Først opslået (Skøn)
19. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20160491
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