Conquering Hypertension in Urban Vietnam

Обзор

The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.

Подробное описание

A Cluster-randomized, Type II Hybrid effectiveness implementation Trial will take place in 14 urban communities in 7 urban districts in Hai Phong city in northern Vietnam.

Community Eligibility Criteria: (1) located in urban Hai Phong city; (2) distance between 2 communities will be at least 10 Km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study.

Recruitment

Residents from participating sites will be invited to attend the community screening events run by local community health center (CHC) staff and Community Health Workers (CHWs). Those meeting our pre-defined eligibility criteria will be invited to their CHCs to learn more about the study. Patients with elevated blood pressure (BP) will be invited for re-measurement over the next two weeks (at least 1 week apart). After the second BP measurement, patients with elevated BP will be invited to participate in the study.

Randomization

Fourteen communities in urban Hai Phong (700 patients with uncontrolled hypertension - HTN) will be randomly assigned either to an intervention (7 communities- 50 patients per community) or comparison group (7 communities- 50 patients per community) by a computer procedure. Patients with uncontrolled HTN will be assigned to intervention versus comparison status based on the communities in which they reside.

Intervention group: The intervention group will receive 3 components including digital Storytelling delivered via Computerized Intervention Authoring System (CIAS), home blood pressure self-monitoring and expanded CHW services (frequent contacts, visits and consultations).

Comparison group: Patients in the comparison group will receive only "Learn More" module - didactic material without HTN related stories via CIAS.

Patients in both groups will be followed up at 3, 6 and 12 months.

Вмешательства

• Поведенческое Storytelling intervention
  The storytelling intervention consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. Based on preferences that emerged during the researchers' formative work with the partnering rural communities, the storytelling intervention will be delivered via Computerized Intervention Authoring System (CIAS) on a biweekly basis. A supplementary "Learn More" module of di
• Поведенческое Home BP monitoring
  Patients with hypertension will be provided blood pressure monitors and guided to self-measure their blood pressure and to record their blood pressure daily at home.
• Поведенческое Expanded community health worker services
  A training program will be implemented for community health workers for the intervention arm regarding hypertension management at the community level so that they can assist patients better managing their blood pressure at home.
• Поведенческое "Learn More" module only
  A supplementary "Learn More" module of didactic material (3 minutes) provides strategies for better patient-physician communication, which will be delivered via Computerized Intervention Authoring System (CIAS) at baseline and at 3, 6, and 9 months after enrollment.

Первичные конечные точки

• Systolic blood pressure level [Срок оценки: From baseline to 3, 6 and 12 month follow up visits]
• Acceptability, Appropriateness, Feasibility [Срок оценки: at 3, 6, and 12 month follow-up visits]
• Adoption [Срок оценки: at baseline, 3, 6, and 12 month follow-up visits]
• Fidelity [Срок оценки: at 3, 6, and 12 month follow-up visits]

Вторичные конечные точки (7)

• Diastolic blood pressure level [Срок оценки: From baseline to 3, 6 and 12 months]
• Hypertension control [Срок оценки: From 3 to 6 and12 months follow up visits]
• Self-efficacy [Срок оценки: From baseline to follow-up at 3, 6, and 12 months]
• Hypertension (HTN) medication adherance [Срок оценки: From baseline to 3, 6, and 12 month follow-up visits]
• Risk of cardiovascular disease (CVD) [Срок оценки: From baseline to follow-up at 12 months]
• Patient quality of life [Срок оценки: From baseline to 3, 6 and 12 month follow up visits]
• Cost [Срок оценки: at 12 month follow up]

Критерии участия

Критерии включения

• Aged ≥18 years old;
• Presence of uncontrolled HTN (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) according to JNC-8;
• Willing to provide informed consent.

Критерии исключения

• Participation in another study on hypertension;
• Pregnant;
• Advanced cognitive impairment;
• Previous exposure to storytelling modules;
• Participant family member;
• Participant in intervention development.

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

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Вьетнам · 1 центр

• Health Strategy and Policy Institute — Hanoi

Публикации

• Ha DA, Tran OT, Nguyen HL, Chiriboga G, Goldberg RJ, Phan VH, Nguyen CT, Nguyen GH, Pham HV, Nguyen TT, Le TT, Allison JJ. Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial. Trials. 2020 Nov 27;21(1):985. doi: 10.1186/s13063-020-04917-8. PMID 33246495
• Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018. PMID 30596749
• Allison JJ, Nguyen HL, Ha DA, Chiriboga G, Ly HN, Tran HT, Phan NT, Vu NC, Kim M, Goldberg RJ. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial. Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6. PMID 26762128
• Ha DA, Tran OM, Nguyen HL, Nguyen HT, Dao AM, Nguyen HV, Vu NC, Chiriboga G, Goldberg RJ, Houston TK, Allison JJ. Stakeholder Engagement in Late-Stage Translation Phase 4 Research for Noncommunicable Diseases in Low- and Middle-Income Countries: What Works and Why-The Vietnam Experience (UMMS-Vietnam Team). Glob Heart. 2019 Jun;14(2):143-147. doi: 10.1016/j.gheart.2019.05.003. PMID 31324368
• Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul. PMID 39045484

Идентификаторы

NCT: NCT06893198 · H00001666 · R61HL172269

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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