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NCT Number: NCT06893198

Conquering Hypertension in Urban Vietnam

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Strategy and Policy Institute

Hanoi, Vietnam, 10000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Storytelling intervention

Behavioral

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.

Home BP monitoring

Behavioral

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.

Expanded community health worker services

Behavioral

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.

"Learn More" module only

Behavioral

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.

Primary outcomes

  1. Systolic blood pressure level

    Time frame: From baseline to 3, 6 and 12 month follow up visits

    Changes in systolic blood pressure levels

  2. Acceptability, Appropriateness, Feasibility

    Time frame: at 3, 6, and 12 month follow-up visits

    Information will be collected via semi-structured interviews among patients, Community health workers, community leaders, and local clinicians and nurses mentioned previously and patient interviews and post-story viewing surveys.

  3. Adoption

    Time frame: at baseline, 3, 6, and 12 month follow-up visits

    Data for participant recruitment and retention will include the number of patients approached for recruitment, reasons for ineligibility of patients not enrolled or refusing to participate, and completion rates for follow-up visits.

  4. Fidelity

    Time frame: at 3, 6, and 12 month follow-up visits

    Information will be collected via periodic random observations of blood pressure measurement and patient interviews by study investigators and the project manager who will document and check intervention deliverables using a standardized checklist.

Secondary outcomes

  1. Diastolic blood pressure level

    Time frame: From baseline to 3, 6 and 12 months

    Changes in diastolic blood pressure levels

  2. Hypertension control

    Time frame: From 3 to 6 and12 months follow up visits

    Changes in the proportion of patients with hypertension control.

  3. Self-efficacy

    Time frame: From baseline to follow-up at 3, 6, and 12 months

    Changes in patients medication adherence self-efficacy, which will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.

  4. Hypertension (HTN) medication adherance

    Time frame: From baseline to 3, 6, and 12 month follow-up visits

    Changes in adherence to anti-HTN medications, which will be measured using a standardized data collection form.

  5. Risk of cardiovascular disease (CVD)

    Time frame: From baseline to follow-up at 12 months

    Changes in CVD risk factors (tobacco use, alcohol consumption, salt intake and physical activities), which will be measured using WHO STEPs questionnaires

  6. Patient quality of life

    Time frame: From baseline to 3, 6 and 12 month follow up visits

    Changes in patient's quality of life, which will be measured using the SF-12 survey.

  7. Cost

    Time frame: at 12 month follow up

    Program costs and patient-related costs will be collected.

    Program costs include intervention development and its implementation at the district and community levels: personnel, equipment, medical devices, training materials and supplies, transportation, administration, and other operational expenses.

    Patient-related costs include medications, time lost from work, Community Health Center visits, and consultation fees and patient utilities will be collected using a survey administered at the final visit.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Health Strategy and Policy Institute
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: HTN-URBAN

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 25, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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