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?
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
Participants who are not able to respond during the data collection period.
Participants who are out of municipality during the data collection period.
Parallel
FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology
Other interventionOur intervention utilizes FCHVs as a bridge between the community and health facilities to improve HTN care. FCHVs and FLHWs will receive 2 days of training to use an Android app. The app provides prompts for BP measurement and educational content on healthy lifestyles. For 3 months, FCHVs will conduct bimonthly meetings, measure BP, height, and weight, provide awareness and enter sociodemographic details of participants into the app. Participants with BP ≥130/85 mmHg (unmedicated) or ≥120/80 mmHg (on medication) will be referred to a nearby health facility by FCHVs. The data entered by FCHVs will be linked to FLHWs' terminals. FLHWs will enter required information about medication use, referrals, and follow-ups into the app and take necessary actions for the treatment of referred patients. The intervention includes 795 participants from 10 clusters with BP ≥130/85 mmHg. Data on BP, medication adherence, quality of life, and physical activity will be collected at baseline and endline.
Change in blood pressure (mmHg)
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.
Change in body weight(kg)
Weight will be measured in kilograms using a weighing scale at health posts by healthcare providers or by FCHVs during group meetings. The measurements will be recorded in the application and later analyzed to assess changes in body weight.
Height (meters)
FLHWs will measure the height (in meters) by using stadiometer at health posts. They will enter the data in the application.
Change in body mass index (BMI) (kg/m²)
Body Mass Index (BMI) will be calculated using the formula BMI = weight (kg) / height² (m²). The BMI values will be derived from the collected data and analyzed to assess changes.
Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)
Quality of life will be assessed using the EuroQol Visual Analogue Scale (EQ VAS), administered by the study team at baseline and endline. Participants will rate their overall health on a vertical visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), and changes in these scores will be used to evaluate improvements in health-related quality of life.
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Duke Kunshan University
Lead sponsor
Dhulikhel Hospital
Collaborator
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