NCT06893198

Conquering Hypertension in Urban Vietnam

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	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 didactic material (3 minutes) provides strategies for better patient-physician communication and is coordinated with the specific patient stories will be provided via CIAS as well.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	"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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2029-02-28
• Completion: 2029-02-28
• First posted: 2025-03-25
• Last updated: 2026-01-27

Locations

1 site across 1 country: Vietnam