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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590691
Recruitment Status : Active, not recruiting
First Posted : July 18, 2018
Last Update Posted : March 11, 2022
Sponsor:
Collaborators:
University of Massachusetts, Worcester
Baylor Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tran Thi Mai Oanh, Ministry of Health, Vietnam

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertension Other: Vietnam National Hypertension Program Other: Expanded community health worker services Behavioral: Storytelling intervention Behavioral: Home blood pressure self-monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster-randomized trial design
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Conquering Hypertension in Vietnam: Solutions at Grassroots Level
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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.
Other: Vietnam National Hypertension Program
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".
Other: Vietnam National Hypertension Program
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

Other: Expanded community health worker services
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.

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

Behavioral: Home blood pressure self-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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590691


Locations
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Vietnam
Health Strategy and Policy Institute
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Ministry of Health, Vietnam
University of Massachusetts, Worcester
Baylor Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Tran Thi Mai Oanh, PhD Health Strategy and Policy Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tran Thi Mai Oanh, Principal Investigator, Director of Health Strategy and Policy Institute, Ministry of Health, Vietnam
ClinicalTrials.gov Identifier: NCT03590691    
Other Study ID Numbers: 5552338110000
1U01HL138631-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tran Thi Mai Oanh, Ministry of Health, Vietnam:
storytelling
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases