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Completed

NCT Number: NCT03590691

Conquering Hypertension in Vietnam: Solutions at Grassroots Level

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Strategy and Policy Institute

Hanoi, 10000, Vietnam

About this study

"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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vietnam National Hypertension Program

Other

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

Expanded community health worker services

Other

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.

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 by DVD, with serial installments at baseline and at 3, 6, and 12 months after trial enrollment.

Home blood pressure self-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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Vietnam

Other Gov

Collaborators

  • Baylor Research Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Massachusetts, Worcester

Registry information

Acronym: HY-TREC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2018
Registry last updated
May 11, 2023

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

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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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