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

NCT07076134 | Not Yet Recruiting DMC

• 2 other identifiers: 437_2024DGHI pilot grant
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months intervention

Secondary Outcomes (6)

• Change in body weight(kg)

  During baseline and endline (3 months intervention period)

• Height (meters)

  At baseline or endline (3 months intervention period)

• Change in body mass index (BMI) (kg/m²)

  Three months intervention period

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

  Three months intervention period

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

  Three months intervention period

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Usual care

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke Kunshan University: lead
• Dhulikhel Hospital: collaborator

Study Sites (1)

Namobuddha municipality

Namobuddha, Kavrepalanchowk, 45200, Nepal

Location

Related Publications (7)

• He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, Chen CS, Gibbons L, Krousel-Wood M, Bazzano LA, Nejamis A, Gulayin P, Santero M, Augustovski F, Chen J, Rubinstein A; HCPIA Investigators. Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1016-1025. doi: 10.1001/jama.2017.11358.

  PMID: 28975305 BACKGROUND

• Lloyd-Sherlock P, Beard J, Minicuci N, Ebrahim S, Chatterji S. Hypertension among older adults in low- and middle-income countries: prevalence, awareness and control. Int J Epidemiol. 2014 Feb;43(1):116-28. doi: 10.1093/ije/dyt215. Epub 2014 Feb 6.

  PMID: 24505082 BACKGROUND

• Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.

  PMID: 26187183 BACKGROUND

• Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.

  PMID: 33909607 BACKGROUND

• Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Mar 9;8(3):e15419. doi: 10.2196/15419.

  PMID: 32149712 BACKGROUND

• Tan J, Xu H, Fan Q, Neely O, Doma R, Gundi R, Shrestha B, Shrestha A, Shrestha S, Karmacharya B, Gu W, Ostbye T, Yan LL. Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study. Glob Heart. 2020 Oct 23;15(1):73. doi: 10.5334/gh.872.

  PMID: 33150138 BACKGROUND

• Bhattarai P, Shrestha A, Xiong S, Peoples N, Ramakrishnan C, Shrestha S, Yin R, Karmacharya B, Yan LL, Jafar TH. Strengthening urban primary healthcare service delivery using electronic health technologies: A qualitative study in urban Nepal. Digit Health. 2022 Jul 21;8:20552076221114182. doi: 10.1177/20552076221114182. eCollection 2022 Jan-Dec.

  PMID: 35898291 BACKGROUND

Related Links

• The WHO Nepal launched the Hypertension Care Cascade Initiative on May 17, 2023, aiming to improve hypertension prevention and treatment across the country. This initiative focuses on strengthening healthcare systems and enhancing community-based care
• The clinical trial NCT06163859 focuses on evaluating the effectiveness of a new intervention for managing hypertension. The study aims to improve patient outcomes and refine treatment strategies

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Lijing Prof. Lijing Yan

CONTACT

86 186 1038 3698; lijing.yan@duke.edu

Dr. Abha Shrestha

CONTACT

9801315233; shresthabha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: July 21, 2025
• Study Start: August 15, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)