Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial

Abstract

Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. 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 the Vietnamese population unless effective prevention and control measures are put in place. 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. Methods Sixteen communities will be randomized to either an intervention (8 communities) or a 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. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a “storytelling intervention,” which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. Discussion Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. Trial registration ClinicalTrials.gov NCT03590691. Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.

Effectiveness of community-based health education and home support program to reduce blood pressure among patients with uncontrolled hypertension in Nepal: A cluster-randomized trial

“…It was estimated based on the fact that normalized blood pressure can be achieved in 25% of uncontrolled hypertensive patients after health education while only 5.2% of patients achieve controlled blood pressure through usual care [ 15 ]. After the literature review, we used an inter-cluster correlation (ICC) = 0.01 for community-based hypertension trial to adjust for the design effect [ 16 ]. During the implementation of the research, we managed to randomize a total of 125 participants in either arm.…”

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

“…The present study was conducted within the context of an ongoing clinical trial entitled "Conquering Hypertension in Vietnam-Solutions at Grassroots Level: Study Protocol of a Cluster Randomized Controlled Trial" in Hung Yen province in northern Vietnam. Details of the trial design have been previously published [17]. The objectives of the parent trial were 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 aged 25 years and older in Vietnam through the use of a cluster-randomized trial design.…”

Cost-utility analysis of community-based interventions for hypertension control in Vietnam

“…With the desire to control hypertension in Vietnam, the program "Conquering Hypertension in Vietnam: Solutions from Grassroots Health" was developed [5]. Between 2020 and 2021, a cluster randomized controlled trial (RCT) of a community-based intervention included 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" was conducted in Hung Yen province, Vietnam [5].…”

“…With the desire to control hypertension in Vietnam, the program "Conquering Hypertension in Vietnam: Solutions from Grassroots Health" was developed [5]. Between 2020 and 2021, a cluster randomized controlled trial (RCT) of a community-based intervention included 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" was conducted in Hung Yen province, Vietnam [5]. In sixteen communities, 671 adult men and women with uncontrolled hypertension were randomly allocated to either an intervention or a comparison group to evaluate the effectiveness of the multi-faceted intervention on the control of elevated blood pressure.…”