Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx)
8 de febrero de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
54
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Ontario
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Ottawa, Ontario, Canadá, K1Y 4W7
- University of Ottawa Heart Insititue
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Ottawa, Ontario, Canadá, K1Y4W7
- University of Ottawa Heart Institute
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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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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Sin intervención: Control group, Standard care
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in number of participants who use the PiezoRx device
Periodo de tiempo: One year (Baseline to 12 weeks, and baseline to 52 weeks)
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in moderate to vigorous physical activity time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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One year (Baseline to 12 weeks, and baseline to 52 weeks)
|
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Changes in fasting glycosylated hemoglobin
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Reed, PhD MEd, CS, Ottawa Heart Institute Research Corporation
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2016
Finalización primaria (Actual)
1 de diciembre de 2019
Finalización del estudio (Actual)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2016
Publicado por primera vez (Estimar)
19 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
8 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20160491
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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