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

Duke Kunshan University

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Other: FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology

Study type: Interventional

Funder types: Other

Identifiers

NCT07076134

437_2024

DGHI pilot grant (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Participants who are not able to respond during the data collection period.
• Participants who are out of municipality during the data collection period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Intervention group

Experimental group

Description:

FCHVs and FLHWs will be given 2 days training on Android mobile-based application usage. The app includes prompts regarding patients' current BP measurements and educational content on dietary habits, the importance of physical activity, and the harmful effects of smoking and alcohol consumption. FCHVs will conduct bimonthly meetings with groups of hypertensive patients. They will measure BP, enter it in the app, provide awareness and refer to nearby health facilities if needed. Data entered by FCHVs will be synchronized with FLHWs' accounts, allowing them to view the data entered by FCHVs. After a patient visits a health facility, the FLHW will take action as needed and record it in the app, thereby creating a linkage between the community and the health facility. Patients registered in the app will also receive weekly health education text messages on their mobile phones.

Treatment:

Other: FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology

Usual care

No Intervention group

Description:

Usual care refers to the standard treatment that participants receive as part of their regular routine, without the research introducing any new interventions. The FCHVs and FLHWs in the usual care group will not receive training on application usage, and the participants will not receive text messages on their mobile phones.