Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx)
8 février 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
54
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Ontario
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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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
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Aucune intervention: Control group, Standard care
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in number of participants who use the PiezoRx device
Délai: 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.
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Change in frequency of using the PiezoRx device
Délai: 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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in moderate to vigorous physical activity time
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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)
|
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Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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
Délai: 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
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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Changes in fasting blood HbA1c (%) 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 body weight
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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Changes in body weight (kg) 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 body mass index
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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Changes in BMI (kg/m2) 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 waist circumference
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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
Délai: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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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One year (Baseline to 12 weeks, and baseline to 52 weeks)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Jennifer Reed, PhD MEd, CS, Ottawa Heart Institute Research Corporation
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2016
Achèvement primaire (Réel)
1 décembre 2019
Achèvement de l'étude (Réel)
1 décembre 2019
Dates d'inscription aux études
Première soumission
1 juillet 2016
Première soumission répondant aux critères de contrôle qualité
14 juillet 2016
Première publication (Estimation)
19 juillet 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 février 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 février 2022
Dernière vérification
1 février 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20160491
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .