Conquering Hypertension in Urban Vietnam (HTN-URBAN)

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Hypertension

Treatments: Behavioral: Home BP monitoring; Behavioral: Storytelling intervention; Behavioral: "Learn More" module only; Behavioral: Expanded community health worker services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06893198

H00001666

R61HL172269 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Comparison Group

Active Comparator group

Description:

Patients in the comparison group will receive the "Learn More" module only.

Treatment:

Behavioral: "Learn More" module only

Intervention Group

Experimental group

Description:

Patients in the intervention group will receive HTN-URBAN intervention, which includes three integrated components: (1) Storytelling intervention, (2) Home BP monitoring, (3) Expanded community health worker services.

Treatment:

Behavioral: Expanded community health worker services

Behavioral: Storytelling intervention

Behavioral: Home BP monitoring