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, particular...
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doaj-0bcfe8b7a835419c88905ff69833ed802020-11-29T12:14:22ZengBMCTrials1745-62152020-11-0121111410.1186/s13063-020-04917-8Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trialDuc A. Ha0Oanh T. Tran1Hoa L. Nguyen2Germán Chiriboga3Robert J. Goldberg4Van H. Phan5Cuc T. Nguyen6Giang H. Nguyen7Hien V. Pham8Thang T. Nguyen9Thanh T. Le10Jeroan J. Allison11Ministry of HealthHealth Strategy and Policy InstituteDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical SchoolDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical SchoolDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical SchoolHealth Strategy and Policy InstituteHealth Strategy and Policy InstituteHealth Strategy and Policy InstituteHealth Strategy and Policy InstituteHealth Strategy and Policy InstituteNational Heart InstituteDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical SchoolAbstract 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.https://doi.org/10.1186/s13063-020-04917-8HypertensionSelf-monitoring blood pressureStorytellingTrialVietnam |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Duc A. Ha Oanh T. Tran Hoa L. Nguyen Germán Chiriboga Robert J. Goldberg Van H. Phan Cuc T. Nguyen Giang H. Nguyen Hien V. Pham Thang T. Nguyen Thanh T. Le Jeroan J. Allison |
spellingShingle |
Duc A. Ha Oanh T. Tran Hoa L. Nguyen Germán Chiriboga Robert J. Goldberg Van H. Phan Cuc T. Nguyen Giang H. Nguyen Hien V. Pham Thang T. Nguyen Thanh T. Le Jeroan J. Allison Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial Trials Hypertension Self-monitoring blood pressure Storytelling Trial Vietnam |
author_facet |
Duc A. Ha Oanh T. Tran Hoa L. Nguyen Germán Chiriboga Robert J. Goldberg Van H. Phan Cuc T. Nguyen Giang H. Nguyen Hien V. Pham Thang T. Nguyen Thanh T. Le Jeroan J. Allison |
author_sort |
Duc A. Ha |
title |
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
title_short |
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
title_full |
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
title_fullStr |
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
title_full_unstemmed |
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
title_sort |
conquering hypertension in vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-11-01 |
description |
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. |
topic |
Hypertension Self-monitoring blood pressure Storytelling Trial Vietnam |
url |
https://doi.org/10.1186/s13063-020-04917-8 |
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