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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Change in number of participants who use the PiezoRx device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in number of participants who use the PiezoRx device
时间窗: 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
时间窗: 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.
次要结局
- Changes in blood pressure(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.(7 days)
- Changes in moderate to vigorous physical activity time(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(One year)
- Changes in body mass index(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in body weight(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in blood lipids(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in waist circumference(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in fasting glycosylated hemoglobin(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in resting heart rate(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Changes in anxiety and depression(One year (Baseline to 12 weeks, and baseline to 52 weeks))
- Validation of Physical activity questionnaire(One year)
研究者
Jennifer Reed
Associate Scientist
Ottawa Heart Institute Research Corporation