A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Health-promoting behaviours
研究概览
简要总结
A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.
详细描述
Aim: To evaluate the effects of a personalised mHealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care.
Design: A 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted.
Participants: People who aged between 40 and 64, mentally competent, have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher, communicable in Chinese and free from stroke and transient ischemic attack (TIA) or other cardiovascular disease will be eligible to the study. A total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group.
Intervention: A theory-based mHealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese ethnic
- •able to read Chinese and communicate in Cantonese/Mandarin
- •with non-laboratory IHRS score 10 or higher
排除标准
- •mentally incompetent
- •previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
- •with eye or retinal disease
- •with terminal disease with an expected life expectancy less than six months
- •being pregnant
- •have enrolled in other lifestyle-based or exercise-based projects
- •do have mobile devices or internet service to access the mobile application
结局指标
主要结局
Health-promoting behaviours
时间窗: 6-month post-allocation
Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.
次要结局
- Self-efficacy of adopting health-promoting behaviours(3-month post-allocation)
- Change in Body mass index (BMI)(Between baseline and 3-month post-allocation)
- Change in Blood lipid profile(Between 3-month and 6-month post-allocation)
- INTERHEART risk score(6-month post-allocation)
- Change in Waist-hip ratio (WHR)(Between 3-month and 6-month post-allocation)
- Change in Fasting blood glucose(Between 3-month and 6-month post-allocation)
- Self-efficacy(6-month post-allocation)
- automatic retinal image analysis (ARIA)(6-month post-allocation)
- Change in Body mass index(BMI)(Between 3-month and 6-month post-allocation)
- automatic retinal image analysis(3-month post-allocation)
- Change in Blood pressure(Between 3-month and 6-month post-allocation)
- Psychological distress(6-month post-allocation)
研究者
Dr. Helen YL Chan
Associate Professor (Dr)
Chinese University of Hong Kong