A Pilot Trial of a Community-and Primary Care-based Intervention Linked With mObile Technology for Hypertension Control in Nepal (CoPILOT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Change in blood pressure (mmHg)
研究概览
简要总结
The clinical trial aims to evaluate whether a community and primary care-based intervention linked with mobile technology (CoPILOT) is acceptable, effective, cost-effective, sustainable, and scalable in improving hypertension (HTN) control among individuals aged 30 to 70 in Nepal. The primary research questions include:
Is the use of the application by Frontline Health Workers (FLHWs) and Female Community Health Volunteers (FCHVs) feasible and acceptable? Can FCHVs equipped with mHealth technology effectively increase the linkage of individuals with elevated blood pressure (BP) to health facilities? Does a mobile-based lifestyle intervention reduce or control BP? Can adherence to prescribed HTN treatments be improved among patients through this intervention?
详细描述
The researcher will compare the intervention and control groups to assess changes in BP, quality of life (QoL), body mass index (BMI), medication adherence, and linkage to care.
Participants in the intervention group will:
Attend bi-monthly meetings conducted by FCHVs for BP measurement, facilitated through the mobile application.
Receive healthy lifestyle awareness guidance provided by FCHVs via the mobile app and supplemented with text message reminders.
Visit nearby health facilities for monthly follow up.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patient's should be in the range of 30 to 70 years old living in selected communities with HTN (systolic BP ≥ 130 mmHg or diastolic ≥ 85 mmHg or taking antihypertensive medication)
- •They should have been diagnosed previously and under medication.
- •They should agree to the informed consent
- •FCHVs should be working for the selected communities and agree to the informed consent
- •FLHWs should work for the health facilities in selected communities and agree to the informed consent.
排除标准
- •Participants who are not able to respond during the data collection period.
- •Participants who are out of municipality during the data collection period.
结局指标
主要结局
Change in blood pressure (mmHg)
时间窗: Three months intervention
Change in systolic and diastolic blood pressure (mmHg) among hypertensive patients in the intervention group will be measured using a validated digital blood pressure monitor at baseline and endline. The outcome will be reported as the mean change in systolic and diastolic blood pressure.
次要结局
- Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews(Three months intervention period)
- Change in body weight(kg)(During baseline and endline (3 months intervention period))
- Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)(Three months intervention period)
- Height (meters)(At baseline or endline (3 months intervention period))
- Change in body mass index (BMI) (kg/m²)(Three months intervention period)
- Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews(Three months intervention period)
- Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS)(Three months intervention period)