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NCT Number: NCT07076134

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

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?

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namobuddha municipality

Namobuddha, Kavrepalanchowk, 45200, Nepal

Location contact

Karma Lama

CONTACT

[email protected]

9851255760 ext. +977

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Change in blood pressure (mmHg)

    Time frame: 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.

Secondary outcomes

  1. Change in body weight(kg)

    Time frame: During baseline and endline (3 months intervention period)

    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.

  2. Height (meters)

    Time frame: At baseline or endline (3 months intervention period)

    FLHWs will measure the height (in meters) by using stadiometer at health posts. They will enter the data in the application.

  3. Change in body mass index (BMI) (kg/m²)

    Time frame: Three months intervention period

    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.

  4. Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)

    Time frame: Three months intervention period

    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.

  5. Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS)

    Time frame: Three months intervention period

    Medication adherence will be assessed using the Morisky Green Levine Medication Adherence Scale (MGLS), administered by the study team at baseline and endline. The MGLS is a 4-item self-report scale that assesses medication-taking behavior, with each item scored 1 for "No" and 0 for "Yes." Total scores range from 0 to 4, with higher scores indicating better adherence. The outcome will be reported as the change in MGLS total score over the 3-month intervention period.

  6. Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews

    Time frame: Three months intervention period

    Empowerment will be assessed through qualitative semi-structured interviews conducted with FCHVs and FLHWs at both baseline and endline. Interview questions will explore changes in core dimensions of empowerment, including knowledge, confidence, and role perception, in relation to the hypertension mHealth intervention. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. The outcome will be reported as a summary of key themes and illustrative quotes that reflect perceived changes in empowerment over the 3-month intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Abha Shrestha

CONTACT

[email protected]

9801315233 ext. 977

Lijing Prof. Lijing Yan

CONTACT

[email protected]

86 186 1038 3698

Sponsors and collaborators

Lead sponsor

Duke Kunshan University

Other

Collaborators

  • Dhulikhel Hospital

Registry information

Official study title

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

Acronym: CoPILOT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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