Clinical trial NCT03590691: Conquering Hypertension in Vietnam: Solutions at Grassroots Level
Official title: Conquering Hypertension in Vietnam: Solutions at Grassroots Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: storytelling
Lead sponsor: Ministry of Health, Vietnam
Sponsor class: OTHER_GOV
Collaborators: name: University of Massachusetts, Worcester
name: Baylor Research Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-07-18
Enrollment: 671
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized trial design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in systolic blood pressure at 12 months
timeFrame: At baseline and at 3, 6, and 12 months after trial enrollment
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure at 12 months
timeFrame: At baseline and at 3, 6, and 12 months after trial enrollment
measure: Change from baseline in medication adherence self-efficacy score at 12 months
timeFrame: At baseline and 12 months after trial enrollment
measure: Changes from the baseline in proportions of patients with risk factors for CVD at 12 months
timeFrame: At baseline and 12 months after trial enrollment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Health Strategy and Policy Institute
Study officials:
affiliation: Health Strategy and Policy Institute
name: Tran Thi Mai Oanh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen 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.
citation: Ha 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.