Improving Care for Adults With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.
详细描述
The goal of this clinical trial study is to learn whether a digital multi-component intervention would increase the knowledge, self-efficacy, self-advocacy, and patient engagement skills of adults with congenital heart disease (CHD) to confidently navigate the health care system and have timely recommended specialist visits.
The multicomponent intervention contains features such as a digital medical passport, updated health-related specific information, opportunities to engage with CHD community, peer-support, doctor visit reminders, etc. The intervention components are designed with inputs from the patients and the CHD community and have the potential to be adapted on an ongoing basis depending on the needs of the patients.
The main question it aims to answer is:
Does the digital multi-component CHD patient engagement intervention enhance the patient engagement skills and lead to timely specialist visit?
Participants will be recruited from the clinics, through word of mouth, social media, and others. Participants can use the website link or a QR code to sign an electronic consent form to be eligible to participate. Once consented, the participants will receive surveys to collect baseline and health status information as well as intervention components at regular intervals. The study will be available for participants to join on the web or mobile, depending on their preferences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 congenital heart disease
- •18 years or older
- •can sign the informed consent
排除标准
- •developmentally delayed
- •unable to consent
研究组 & 干预措施
Intervention
This is a digital (web and mobile-based) multicomponent patient engagement behavioral intervention. The intervention components include digital medical passport, health-specific updated information, credible resources, connections with the community, peer- and expert support and guidance, among others
干预措施: Digital patient empowerment intervention (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 6-12 months
Number of patients recruited out of all the eligible patient approached for recruitment
Satisfaction with the intervention components
时间窗: 0, 6 and 12 months
Scores on client satisfaction questionnaire (CSQ-8) survey. Scores are summed across items once. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Acceptability of the intervention components
时间窗: 0, 6 and 12 months
Rates of app downloads. The investigators will download app data monthly to evaluate the frequency and duration of the use of various intervention components. The investigators will recruit 10 participants for focused group discussions on acceptability of the app.
Feasibility of the intervention
时间窗: 0, 6 and 12 months
Ability to download the app or any technical difficulties with the app or its features.
次要结局
- Patient activation measure (PAM)(0, 6, 12 months)
- Gothenburg Empowerment Scale (GES)(0, 6, 12 months)
- Timely specialist visit(24 - 36 months)
- Euro-Quality of Life(0, 6, 12, and 24 months)