Clinical trial NCT06893198: Conquering Hypertension in Urban Vietnam
Official title: Conquering Hypertension in Urban Vietnam
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: storytelling intervention
home blood pressure monitoring
community health workers
Urban hypertension
Vietnam
HTN-URBAN intervention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Health Strategy and Policy Institute
First posted: 2025-03-25
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Systolic blood pressure level
timeFrame: From baseline to 3, 6 and 12 month follow up visits
measure: Acceptability, Appropriateness, Feasibility
timeFrame: at 3, 6, and 12 month follow-up visits
measure: Adoption
timeFrame: at baseline, 3, 6, and 12 month follow-up visits
measure: Fidelity
timeFrame: at 3, 6, and 12 month follow-up visits
Secondary outcomes:
measure: Diastolic blood pressure level
timeFrame: From baseline to 3, 6 and 12 months
measure: Hypertension control
timeFrame: From 3 to 6 and12 months follow up visits
measure: Self-efficacy
timeFrame: From baseline to follow-up at 3, 6, and 12 months
measure: Hypertension (HTN) medication adherance
timeFrame: From baseline to 3, 6, and 12 month follow-up visits
measure: Risk of cardiovascular disease (CVD)
timeFrame: From baseline to follow-up at 12 months
measure: Patient quality of life
timeFrame: From baseline to 3, 6 and 12 month follow up visits
measure: Cost
timeFrame: at 12 month follow up
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Health Strategy and Policy Institute
Study officials:
affiliation: University of Massachusetts, Worcester
name: Hoa Nguyen, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.