A Cluster Randomized Trial to Evaluate Comprehensive Approach to Hypertension Management in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,252
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure (BP) (mmHg)
研究概览
简要总结
Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.
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
- 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
- •Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication)
- •Living in the area served by the participating health facilities
排除标准
- •Pregnancy
- •Not able or willing to give informed consent,
- •Critically ill from depilating conditions such as dialysis, cancer, palliative care
- •Not likely to continue living in the area served by the health facility during trial follow up period (8 months)
结局指标
主要结局
Mean systolic blood pressure (BP) (mmHg)
时间窗: Measured at baseline and follow up between 7 to 8 months after baseline
Net change in mean systolic BP from baseline to follow up
次要结局
- Mean diastolic BP (mmHg)(Measured at baseline and follow up between 7 to 8 months after baseline)
- Proportion controlling BP (<140/90 mmHg)(Measured at baseline and follow up between 7 to 8 months after baseline)
- Waist Circumference (cm)(Measured at baseline and follow up between 7 to 8 months after baseline)
- Body weight (Kg)(Measured at baseline and follow up between 7 to 8 months after baseline)
- Diet low in cholesterol, high in fruits and vegetables(Reported at baseline and follow up between 7 to 8 months after baseline)
- Hypertension Knowledge Score(Self reported at baseline and follow up between 7 to 8 months after baseline)
- Daily salt intake (<1 teaspoon per day)(Reported at baseline and follow up between 7 to 8 months after baseline)
- Medication adherence(Self reported at baseline and follow up between 7 to 8 months after baseline)
- Physical activity(Self reported at baseline and follow up between 7 to 8 months after baseline)
- Perceived Social Support Scale(Self reported at baseline and follow up between 7 to 8 months after baseline)
- Maintaining BP logs(Self reported at follow up between 7 to 8 months after baseline)