Journal Article

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

Ha, Duc A., Nguyen, Cuc T., Phan, Van H., Le, Thanh T., Nguyen, Hoa L., Pham, Hien V., Nguyen, Thang T., Tran, Oanh T., Chiriboga, Germán, Allison, Jeroan J., Nguyen, Giang H., Goldberg, Robert J.

2020

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Biomedicine / Blood pressure / Cardiovascular disease / Cardiovascular Diseases / Care and treatment / Clinical trials / Community health care / Community health services / Community Health Workers / Cost-Benefit Analysis / Health care policy / Health facilities / Health insurance / Health promotion / Health Sciences / Humans / Hypertension / Hypertension - diagnosis / Hypertension - epidemiology / Intervention / Medicine / Medicine & Public Health / Methods / Outpatient care facilities / Patient compliance / Population / Primary care / Randomized Controlled Trials as Topic / Self-monitoring blood pressure / Statistics for Life Sciences / Storytelling / Study Protocol / Trial / Vietnam / Vietnam - epidemiology