HypertensionHY-TRECNCT03590691
Conquering Hypertension in Vietnam: Solutions at Grassroots Level
A study testing Vietnam National Hypertension Program, Expanded community health worker services and Storytelling intervention in people with Hypertension, run by Ministry of Health, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Vietnam National Hypertension Program, Expanded community health worker services and Storytelling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Nov 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- participation in another hypertension research study;
- pregnant;
- advanced cognitive impairment; or
- previous participation in developing or having exposure to the hypertension storytelling modules.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Vietnam National Hypertension Program, Expanded community health worker services, Storytelling intervention, Home blood pressure self-monitoring
- Keywords
- storytelling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vietnam National Hypertension ProgramOther
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 servicesOther
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 interventionBehavioural
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-monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | Active comparator | Vietnam National Hypertension Program: a training program for health care workers and a health educational program for general public. Receives: Other: Vietnam National Hypertension Program |
| Intervention group | Experimental | 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". Receives: Other: Vietnam National Hypertension Program; Other: Expanded community health worker services; Behavioral: Storytelling intervention; Behavioral: Home blood pressure self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in systolic blood pressure at 12 months
Changes in systolic blood pressure will be assessed in both study groups at several follow-up time points.
Measured: At baseline and at 3, 6, and 12 months after trial enrollment
Secondary outcomes (3)
Change from baseline in diastolic blood pressure at 12 months
Changes in diastolic blood pressure will be assessed in both study groups at several follow-up time points.
Measured: At baseline and at 3, 6, and 12 months after trial enrollment
Change from baseline in medication adherence self-efficacy score at 12 months
Patients medication adherence self-efficacy will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.
Measured: At baseline and 12 months after trial enrollment
Changes from the baseline in proportions of patients with risk factors for CVD at 12 months
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.
Measured: At baseline and 12 months after trial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start7 Nov 2019
- Primary completion31 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized trial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Vietnam
- Sponsor type
- Other government
- Collaborators
- University of Massachusetts, Worcester, Baylor Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Tran Thi Mai Oanh, Ministry of Health, Vietnam
- Investigators
- Tran Thi Mai Oanh, PhD, Principal investigator, Health Strategy and Policy Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590691
- Sponsor's protocol ID
- 5552338110000
- Other IDs
- 1U01HL138631-01
- Acronym
- HY-TREC
- Status last verified
- May 2023
- First submitted
- 31 May 2018
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen CTT, Challagonda J, Ha TS, Nguyen ND, Nguyen HTT, Ha DA, Tran OT, Nguyen PK, Phan VH, Nguyen GH, Nguyen THT, Goldberg RJ, Allison JJ, Wang B, Chiriboga G, Nguyen HL. Health related quality of life among hypertensive adults living in rural Vietnam: Results from a cluster-randomised controlled trial. PLoS One. 2026 May 13;21(5):e0337817. doi: 10.1371/journal.pone.0337817. eCollection 2026.
PubMed 42127005Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.
PubMed 39045484Nguyen HL, Tran OT, Ha DA, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Chiriboga G, Goldberg RJ, Allison JJ. Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam. PLoS One. 2021 Jul 15;16(7):e0253664. doi: 10.1371/journal.pone.0253664. eCollection 2021.
PubMed 34264973Ha DA, Tran OT, Nguyen HL, Chiriboga G, Goldberg RJ, Phan VH, Nguyen CT, Nguyen GH, Pham HV, Nguyen TT, Le TT, Allison JJ. Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial. Trials. 2020 Nov 27;21(1):985. doi: 10.1186/s13063-020-04917-8.
PubMed 33246495
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conquering Hypertension in Vietnam: Solutions at Grassroots Level
- ClinicalTrials.gov ID
- NCT03590691
- Acronym / sponsor ID
- HY-TREC / 5552338110000
- Conditions
- Hypertension
- Keywords
- storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Ministry of Health, VietnamOther government
- Collaborators
- University of Massachusetts, Worcester, Baylor Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A cluster-randomized trial design
| Arm | Type | Receives |
|---|---|---|
| Comparison group | Active comparator | Other: Vietnam National Hypertension ProgramVietnam National Hypertension Program: a training program for health care workers and a health educational program for general public. |
| Intervention group | Experimental | Other: Vietnam National Hypertension Program, Other: Expanded community health worker services, Behavioral: Storytelling intervention, Behavioral: Home blood pressure self-monitoringVietnam 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". |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- participation in another hypertension research study;
- pregnant;
- advanced cognitive impairment; or
- previous participation in developing or having exposure to the hypertension storytelling modules.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vietnam National Hypertension ProgramA 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 | Comparison group, Intervention group |
| Expanded community health worker servicesA 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. | Other | Intervention group |
| Storytelling interventionThe 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. | Behavioural | Intervention group |
| Home blood pressure self-monitoringPatients 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. | Behavioural | Intervention group |
Primary outcome
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.
3 secondary outcomes
Change from baseline in diastolic blood pressure at 12 months
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 42127005Nguyen CTT, Challagonda J, Ha TS, Nguyen ND, Nguyen HTT, Ha DA, Tran OT, Nguyen PK, Phan VH, Nguyen GH, Nguyen THT, Goldberg RJ, Allison JJ, Wang B, Chiriboga G, Nguyen HL. Health related quality of life among hypertensive adults living in rural Vietnam: Results from a cluster-randomised controlled trial. PLoS One. 2026 May 13;21(5):e0337817. doi: 10.1371/journal.pone.0337817. eCollection 2026.
- Derived from this study: PubMed 39045484Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.
- Derived from this study: PubMed 34264973Nguyen HL, Tran OT, Ha DA, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Chiriboga G, Goldberg RJ, Allison JJ. Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam. PLoS One. 2021 Jul 15;16(7):e0253664. doi: 10.1371/journal.pone.0253664. eCollection 2021.
- Derived from this study: PubMed 33246495Ha DA, Tran OT, Nguyen HL, Chiriboga G, Goldberg RJ, Phan VH, Nguyen CT, Nguyen GH, Pham HV, Nguyen TT, Le TT, Allison JJ. Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial. Trials. 2020 Nov 27;21(1):985. doi: 10.1186/s13063-020-04917-8.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tran Thi Mai Oanh, PhD principal investigator
Health Strategy and Policy Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vietnam National Hypertension Program, Expanded community health worker services and Storytelling intervention in people with Hypertension, run by Ministry of Health, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in systolic blood pressure at 12 months (time frame: At baseline and at 3, 6, and 12 months after trial enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590691, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.