A Cluster Randomised Controlled Trial of M-health Enabled, Nurse Care Coordinator Led Intervention to Improve Management of Hypertension in India: m-Power Heart Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,872
- 试验地点
- 14
- 主要终点
- Difference in the mean systolic blood pressure
研究概览
简要总结
This study evaluates the effect of a mobile health technology enabled trained nurse led intervention on control of blood pressure among patients with hypertension seeking care in the community health centres in the southern state of Andhra Pradesh, India. half the community health centres will receive the intervention and the other half will receive the routine care.
详细描述
The burden of hypertension is very high in India but the control rates of hypertension are very low. One of the important reasons for this is the lack of awareness and the inability of the doctors working in busy out patient settings of public health facilities to care adequately for the patients. Hence there is a need for task shifting.
In this trial a trained nurse care coordinator will be placed in the Community Health Centres (CHCs) and she will be provided with an Electronic Decision Support System (EDSS), in the form of an android application installed on a tablet, to treat hypertension. The trial will be carried out in twelve CHCs of Visakhapatnam district in southern Indian state of Andhra Pradesh.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥30 years.
- •Willing to provide written informed consent for the study.
- •Identified as suffering from hypertension (≥160/100 mmHg) with or without co-morbidities such as left ventricular hypertrophy, heart failure, coronary artery disease, peripheral vascular disease, or diabetes mellitus
排除标准
- •Participants aged <30years
- •Unwilling/unable to provide written informed consent for the study
- •Having malignancies or life threatening conditions
- •Currently participating in other clinical trials
- •Those with plans to move residence in the year ahead.
结局指标
主要结局
Difference in the mean systolic blood pressure
时间窗: 12 months
Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention
次要结局
- Compliance to therapy(12 months)
- Follow up with the physician(12 months)
研究者
Dr. Dorairaj Prabhakaran
Executive Director
Centre for Chronic Disease Control, India