NCT07076134

Community-and Primary Care-based Intervention Linked With mObile Technology for HTN Control in Nepal

A Pilot Trial of a Community-and Primary Care-based Intervention Linked With mObile Technology for Hypertension Control in Nepal (CoPILOT Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Duke Kunshan University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology	Our 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.

Timeline

• Start date: 2025-08-15
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-07-21
• Last updated: 2025-08-17

Locations

1 site across 1 country: Nepal