Conquering Hypertension in Vietnam: Solutions at Grassroots Level (HY-TREC)

May 10, 2023 updated by: Tran Thi Mai Oanh, Ministry of Health, Vietnam

The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design.

Sixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside.

Study Overview

Detailed Description

"Đương đầu với bệnh Tăng huyết áp ở Việt Nam: Giải pháp từ Y tế cơ sở (Conquering Hypertension in Vietnam: Solutions at Grassroots level)" (Vietnam Hy-TREC) Background: Similar to other low- and middle-income countries, Vietnam has been experiencing an epidemiologic transition with an increasing burden of non-communicable diseases (NCD). The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in Vietnamese men and women unless effective prevention and control measures are put in place.

Objectives: This project will be evaluating the implementation and effectiveness of two multi-faceted community and clinic-based strategies for the control of hypertension among adults residing in the rural Red River Delta region of Vietnam with uncontrolled hypertension through use of a cluster-randomized trial design.

Study population:Sixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consentingadult study participants with uncontrolled HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside.

Methods: Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program. Components of this program include education and practice change modules for health care providers, accessible reading materials for patients, and a community awareness multi-media program. In addition to the Vietnam National Hypertension Program, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home blood pressure self-monitoring; and (3) a "storytelling intervention," previously developed and pilot tested for feasibility and effectiveness by members of the research team. 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 our formative work with our partnering rural communities, the storytelling intervention will be delivered by DVD, with serial installments at baseline and again at 3, 6, and 12 months after trial enrollment. Differences in changes in blood pressure and other factors will be assessed in both study groups at several follow-up time points. In conjunction with the work done being accomplished during the pilot feasibility study, current efforts by the Vietnam National Hypertension Program, and the proposed investigation, this project addresses a serious clinical and public health problem in Vietnam by implementing the first community-based study using a culturally-literacy appropriate intervention to control elevated blood pressure among the adult Vietnamese population.

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hanoi, Vietnam, 10000
        • Health Strategy and Policy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. residence in a study commune;
  2. at least 25 years old;
  3. presence of uncontrolled HTN based on the screening process described previously and
  4. willingness to provide informed consent.

Exclusion Criteria:

  1. participation in another hypertension research study;
  2. pregnant;
  3. advanced cognitive impairment; or
  4. previous participation in developing or having exposure to the hypertension storytelling modules.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparison group
Vietnam National Hypertension Program: a training program for health care workers and a health educational program for general public.
A training program for health care workers including physicians and nurses and a health educational program for general public regarding hypertension management at community level will be implemented
Experimental: Intervention group

Vietnam National Hypertension Program including training program for health care workers and an health educational program for general public.

PLUS

Three selected enhancements integrated into routine clinical care:

  1. expanded community health worker services;
  2. home blood pressure self-monitoring; and
  3. a "storytelling intervention".
A training program for health care workers including physicians and nurses and a health educational program for general public regarding hypertension management at community level will be implemented
A training program will be implemented for community health workers regarding hypertension management at community level so that they can assist patients better manage their blood pressure at home.
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 by DVD, with serial installments at baseline and at 3, 6, and 12 months after trial enrollment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in systolic blood pressure at 12 months
Time Frame: At baseline and at 3, 6, and 12 months after trial enrollment
Changes in systolic blood pressure will be assessed in both study groups at several follow-up time points.
At baseline and at 3, 6, and 12 months after trial enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in diastolic blood pressure at 12 months
Time Frame: At baseline and at 3, 6, and 12 months after trial enrollment
Changes in diastolic blood pressure will be assessed in both study groups at several follow-up time points.
At baseline and at 3, 6, and 12 months after trial enrollment
Change from baseline in medication adherence self-efficacy score at 12 months
Time Frame: At baseline and 12 months after trial enrollment
Patients medication adherence self-efficacy will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.
At baseline and 12 months after trial enrollment
Changes from the baseline in proportions of patients with risk factors for CVD at 12 months
Time Frame: At baseline and 12 months after trial enrollment
WHO STEPs questionnaires will be used to collect data on risk factors for CVD including tobacco use, alcohol consumption, salt intake and physical activities. Proportions of patients with current smoking, excessive use of alcohol, high salt intake, and low physical activity will be calculated.
At baseline and 12 months after trial enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tran Thi Mai Oanh, PhD, Health Strategy and Policy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5552338110000
  • 1U01HL138631-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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