MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of controlled hypertension 12 weeks after ICH
研究概览
简要总结
This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).
详细描述
140 ICH survivors will be randomized into mobile health intervention (MOBILE) and the usual care group for hypertension management. All subjects will be educated on the importance of hypertension control after ICH and given lifestyle advice, including the DASH diet. Subjects in the MOBILE group will enter their home blood pressure (BP) measurements into a mobile stroke App (WeRISE) daily, and the study team will regularly review the BP measurements through a backend system. A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented. Subjects in the usual care group will have their hypertension managed by their respective treating physicians. All subjects will be followed up for 26 weeks. The primary and secondary endpoints include the rate of controlled hypertension at 12 and 26 weeks.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ICH Diagnosis
- •Age ≥ 18 years
- •Discharge Modified Rankin Scale of ≤4
排除标准
- •Expected life expectancy of <1 year
- •Patient or caregiver does not have access to WeRISE App.
- •Patient or caregiver does not know how to use WeRISE App .
- •Inability to perform home BP monitoring
- •Inability to participate in follow-up activity
- •Contraindication for intensive and rapid lowering of blood pressure (Known >70% cerebral vascular stenosis; History of fall, dizziness or syncope due to hypotension; Any other medical condition that is deemed contraindicated for low blood pressure
- •Bleeding tendency (Platelet count < 75 x 10^9/L; Known coagulation disorder)
- •Severe renal impairment (Estimated glomerular filtration rate using CKD-EPI formula <30 ml/min/1.73m2)
- •Severe liver impairment (Child-Pugh C cirrhosis)
- •Known contraindication or allergy to two or more anti-hypertensive classes
结局指标
主要结局
Rate of controlled hypertension 12 weeks after ICH
时间窗: 12 weeks
Office systolic BP \<130 mmHg
Rate of controlled hypertension 12 weeks after ICH
时间窗: 12 weeks
Office systolic BP \<130 mmHg
次要结局
- Change of BP from recruitment to 12 weeks(12 weeks)
- Rate of controlled hypertension 26 weeks after ICH(26 weeks)
- Life Simple 7 Score at 12 and 26 weeks(12 and 26 weeks)
- Change of BP from recruitment to 12 weeks(12 weeks)
- Rate of controlled hypertension 26 weeks after ICH(26 weeks)
- Life Simple 7 Score at 12 and 26 weeks(12 and 26 weeks)
研究者
Teo Kay-Cheong
Clinical Assistant Professor
The University of Hong Kong