Long-term Effectiveness of an mHealth Intervention for Improving the Disease Knowledge and Physical Activity of Youth With Congenital Heart Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Cardiac disease knowledge
研究概览
简要总结
The aims of this study were to evaluate the long-term effectiveness of the Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with congenital heart disease (CHD). The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.
详细描述
Background: Mobile health initiatives may provide youth with congenital heart disease (CHD) relevant health information and a platform for managing the complex health care needs associated with undergoing transitional care.
Aims: To evaluate the long-term effectiveness of the Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with CHD.
Methods: The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being diagnosed with CHD by a pediatric cardiologist and qualifying as having simple or moderate CHD complexity according to the 2008 American College of Cardiology/American Heart Association guidelines;
- •having a regular pulse;
- •being 15-24 years of age;
- •being conversant in Mandarin and Taiwanese;
- •possessing a smartphone with Internet connection;
- •agreeing to wear an exercise-monitoring wristband to record physiological data;
- •agreeing to engage in exercises designed to test cardiopulmonary endurance;
- •agreeing to participate in the study and sign an informed consent form for a relevant interview. For participants under 20 years of age, guardian approval by signing a written consent form was required.
排除标准
- •having cognitive impairment to the extent of being noncommunicative;
- •having CHD complicated with other congenital abnormalities;
- •having undergone a cardiac catheter-related intervention or surgery within the past 6 months;
- •being pregnant
结局指标
主要结局
Cardiac disease knowledge
时间窗: 12 months
measured by the Leuven Knowledge Questionnaire for CHD
次要结局
- Physical activity(12 months)
研究者
Chi-Wen Chen
Professor
National Yang Ming Chiao Tung University