A Cluster Randomised Controlled Trial to Evaluate the Effectiveness of Digital Health Interventions in Improving Non-communicable Disease Management During the Pandemic in Rural Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,965
- 试验地点
- 2
- 主要终点
- Systolic blood pressure (mmHg) measured in the rural health center
研究概览
简要总结
This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. The main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective.
30 rural health centers in Punjab Province, Pakistan will be randomized into two groups. The intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of NCDs during the pandemic, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Usual care will be provided in the control group. Researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 12 months.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 卫生服务研究
- 盲法
- 单盲 (结局评估者)
盲法说明
The research team will mask the statisticians when data is presented and analyzed.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Reside in the catchment of selected rural health centers;
- Provide informed consent;
- Newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmHg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmHg;
- Have a smartphone or can access a smartphone from a relative.
排除标准
- Patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.
研究组 & 干预措施
Control arm
Usual care, which is routine hypertension and diabetes diagnosis and treatment under the World Diabetes Foundation (WDF) project will be implemented. The WDF project provides initial Zoom-based training of NCD care to rural health center (RHC) staff, but no tele-mentorship is offered. Under the usual care, patients with hypertension or diabetes are required to visit RHCs every month to renew their medications and measure their blood pressure. No other interventional components will be implemented in the control arm.
Intervention arm
A comprehensive package of digital health interventions to connect patients, patient champions and public health providers to improve the management of non-communicable diseases (NCDs) during the pandemic will be implemented, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Patient champions are experienced patients who can provide peer support.
干预措施: Digital health interventions (Other)
结局指标
主要结局
Systolic blood pressure (mmHg) measured in the rural health center
时间窗: At 12 months
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Systolic blood pressure (mmHg) measured in the rural health center
时间窗: At 10 months
次要结局
- Diastolic blood pressure (mmHg) measured in the rural health center(At 12 months)
- Proportion of participants been admitted to district hospitals for any reasons(During the 12-month intervention period)
- Percentage of patients with controlled blood pressure measured below 140/90 mmHg for patients with hypertension but without diabetes, and below 130/80 mmHg for patients with diabetes(At 12 months)
- Random blood glucose (mmol/L)(At 12 months)
- Body mass index (BMI)(At 12 months)
- Number of consultations with RHC doctors, including both in-person and virtual consultations(During the 12-month intervention period)
- Proportion of patients who have had at least three doses of COVID vaccinations(At 12 months)
- All-cause mortality rate(During the 12-month intervention period)
- Diastolic blood pressure (mmHg) measured in the rural health center(At 10 months)
- Systolic and diastolic blood pressure(At 6 months)
- Percentage of patients with controlled blood pressure measured below 140/90 mmHg for patients with hypertension but without diabetes, and below 130/80 mmHg for patients with diabetes(At 10 months)
- Body mass index (BMI)(At 10 months)
- Proportion of participants been admitted to district hospitals for any reasons(During the 10-month intervention period)
- Random blood glucose (mmol/L)(At 10 months)
- Number of consultations with RHC doctors, including both in-person and virtual consultations(During the 10-month intervention period)
- Proportion of patients who have had at least three doses of COVID vaccinations(At 10 months)
- All-cause mortality rate(During the 10-month intervention period)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT05699369
- 其他研究编号
- PRCT202112
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (2年前)
- 研究完成日期
- (2年前)
- 最近核实
- (9个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.