A Cluster-randomized Study on the Risk Assessment and Management Program for Home Blood Pressure Monitoring in Population With Inadequate Health Literacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 主要终点
- Change in Clinic Blood Pressure control rate
研究概览
简要总结
Clinical Trial: The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve patients with uncontrolled hypertensions drug adherence, and therefore improve their BP level in primary care setting. The investigators will invite total 270 patients from 5 general outpatient clinic (GOPCs) to participate the trial.
Qualitative study: The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring by individually interviewing 30 selected patients with uncontrolled hypertension
详细描述
Background Recent oversea randomized control trials have proven effectiveness of lowering clinic and home BP if uncontrolled hypertensive patients were taught to perform home BP monitoring properly with validated BP device. Patients were taught to response to home BP reading (e.g. follow drug regime, or doctor adjust drug according to patients' home BP record)
Study design 1. Prospective cluster randomized control trial, 2. Qualitative individual interview
Aims The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve older adults with uncontrolled hypertension drug adherence, and therefore improve their BP level in a primary care setting. The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring
Subjects Adult Chinese on hypertensive treatment more than 12 months with uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥80. You will be invited to participate if you are willing and capable to perform self-home BP monitoring on daily basis.
Sample size 270 (45 people from each clinic); 30 people for qualitative interview
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on hypertensive treatment
- •uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥
- •willing and capable to perform home BP monitoring by themselves on daily basis. -
排除标准
- •unable to perform the home monitoring either by themselves
- •mentally incapacitated
- •arrhythmias
- •unstable angina
- •serum creatinine > 250 mmol/l
- •orthostatic hypotension
- •severe left ventricular impairment
- •severe aortic stenosis
结局指标
主要结局
Change in Clinic Blood Pressure control rate
时间窗: 18 months
After 18 months of treatment, to compare BP control rate in the intervention group and the control group.
次要结局
- Change of fasting blood sugar level(18 months)
- Proportion of subjects with normal body mass index(18 months)
- Change in mean clinic Systolic blood pressure (SBP) intervention group when compare with control group(6 months, 12 months and 18 months)
- Qualitative study of patients' view and experience of home blood pressure monitoring(5 patients are interviewed before intervention, 6 weeks post-intervention, different time frame after patients' hypertension diagnosed)
- Change of low density lipoprotein level (LDL)(18 months)
- Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group(6 months, 12 months and 18 months)
研究者
Dr. Sau-nga Fu
Ph D Student
The University of Hong Kong