A Shared Decision Making Approach With Digital Support to Improve Quality of Life, Exercise Capacity, Motivation to Exercise, Perception of Rehabilitation and Engagement in the Decision Making Process in Patients With Coronary Artery Disease in a Cardiac Rehabilitation Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Heart-related Quality of Life
研究概览
简要总结
Investigating the role of shared-decision making in cardiac rehabilitation
详细描述
The clinical study is a prospective double-arm, randomized controlled trial to study the user experience of the approach with the supporting applications, and the impact on patients' quality of life, physical activity, perception of rehabilitation and engagement in the decision making process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a history of coronary artery disease with or without intervention (PCI/CABG/conservative)
- •Be clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test
- •Recently having started cardiac rehabilitation in Jessa Hospital Hasselt
- •Age ≥18 years
- •Willing and physically able to follow a technology-supported shared decision making program and other study procedures in a three months follow-up period
- •Show evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
- •Possession of and/or able to use an Android based smartphone
- •Possession of internet connectivity
- •Dutch speaking and understanding
排除标准
- •• Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow a technology-supported shared decision making program
- •Planned interventional procedure or surgery in the next three months
- •Pregnant females
- •Present cardiovascular complaints
- •Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
- •Current or recent participation in other technology-supported programs, even when not directly targeting exercise capacity
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigators judgement
研究组 & 干预措施
Control group
Participating in regular cardiac rehabilitation
干预措施: SharedHeart (Device)
Intervention
Participating in regular cardiac rehabilitation + using the shared-decision making application
干预措施: SharedHeart (Device)
结局指标
主要结局
Heart-related Quality of Life
时间窗: 3 months
The Heart-related Quality of Life will be assesed with a validated questionnaire "HeartQoL". The questionnaire will be administered to the patient at baseline and after 3 months on paper.
次要结局
- Exercise capacity change(3 months)
研究者
prof. dr. Paul Dendale
Head of Cardiology
Hasselt University