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

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Другое 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 mm

Первичные конечные точки

• Change in blood pressure (mmHg) [Срок оценки: Three months intervention]

Вторичные конечные точки (6)

• Change in body weight(kg) [Срок оценки: During baseline and endline (3 months intervention period)]
• Height (meters) [Срок оценки: At baseline or endline (3 months intervention period)]
• Change in body mass index (BMI) (kg/m²) [Срок оценки: Three months intervention period]
• Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS) [Срок оценки: Three months intervention period]
• Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS) [Срок оценки: Three months intervention period]
• Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews [Срок оценки: Three months intervention period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Nepal · 1 центр

• Namobuddha municipality — Namobuddha

Публикации

• 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. d PMID 28975305
• 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
• 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. Circula PMID 26187183
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07076134 · 437_2024 · DGHI pilot grant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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