Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx)
8. Februar 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
54
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1Y 4W7
- University of Ottawa Heart Insititue
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Ottawa, Ontario, Kanada, K1Y4W7
- University of Ottawa Heart Institute
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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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Kein Eingriff: Control group, Standard care
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in number of participants who use the PiezoRx device
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in moderate to vigorous physical activity time
Zeitfenster: 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.
|
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
Zeitfenster: 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
|
|
Validation of Physical activity questionnaire
Zeitfenster: One year
|
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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
|
One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
|
Changes in blood lipids
Zeitfenster: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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Changes in total cholesterol, HDL, LDL, and Triglycerides (mmol/L) from baseline to follow-ups
|
One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in fasting glycosylated hemoglobin
Zeitfenster: 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
Zeitfenster: 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)
|
|
Changes in body mass index
Zeitfenster: One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Jennifer Reed, PhD MEd, CS, Ottawa Heart Institute Research Corporation
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2016
Primärer Abschluss (Tatsächlich)
1. Dezember 2019
Studienabschluss (Tatsächlich)
1. Dezember 2019
Studienanmeldedaten
Zuerst eingereicht
1. Juli 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Juli 2016
Zuerst gepostet (Schätzen)
19. Juli 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Februar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Februar 2022
Zuletzt verifiziert
1. Februar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20160491
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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