越南高血压防治：一项整群随机对照试验的12个月随访结果

Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial.

作者信息

Nguyen Hoa L, Ha Duc A, Tran Oanh T, Phan Van H, Nguyen Cuc T, Nguyen Giang H, Nguyen Thang T, Le Thanh T, Goldberg Robert J, Wang Bo, Tang Elena T, Chiriboga Germán, Budhwani Henna, Allison Jeroan J

机构信息

Department of Population and Quantitative Health Sciences, UMass Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, USA.

Viet Nam Ministry of Health, 138 Giang Vo Street, Ba Dinh District, Ha Noi, Viet Nam.

出版信息

Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.

DOI:10.1016/j.lanwpc.2024.101123

PMID:39045484

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11263625/

Abstract

BACKGROUND

Approximately 20% of adults in Vietnam have hypertension, and management of this chronic condition remains challenging. This study aimed to assess the effectiveness of a multicomponent intervention in reducing blood pressure (BP) in adults with uncontrolled hypertension.

METHODS

This cluster randomised controlled trial was conducted in sixteen communities (8 intervention and 8 comparison) in a rural setting in Vietnam (2017-2022). Consenting adults (aged ≥ 18 years) with uncontrolled hypertension were enrolled. Sixteen communities were equally randomised to an intervention or comparison group stratified by district. Consenting adults were assigned to study groups by community. The comparison arm received training sessions about hypertension prevention and management for health workers, and patient education materials. The intervention arm received training sessions about hypertension prevention and management for health workers, and patient education materials and three enhancement components including a storytelling intervention, home BP self-monitoring, and expanded community health worker services. The primary outcome was the difference in changes in patient's levels of systolic BP between the study groups over a 12-month follow-up period. Patients and outcome assessors were masked.

FINDINGS

A total of 671 patients (340: intervention, 331: comparison) were enrolled in the trial. The mean age was 66 years and 45% were men. At the 12-month follow-up, the mean systolic BP declined by 18.4 mmHg in the intervention group and 3.7 mmHg in the comparison group (differential decline of 14.7 mmHg [95% CI: 11.8-17.6]). The intervention group also achieved better BP control and medication adherence than the comparison group. There were no serious adverse events related to study participation.

INTERPRETATION

The results of this trial demonstrate that a multicomponent intervention can effectively reduce elevated BP in individuals with uncontrolled hypertension in Vietnam. Trial registration: This trial was registered at ClinicalTrials.gov, NCT03590691.

FUNDING

National Heart, Lung, and Blood Institute.

摘要

背景

越南约20%的成年人患有高血压，对这种慢性病的管理仍然具有挑战性。本研究旨在评估多组分干预措施对血压未得到控制的成年高血压患者降低血压的效果。

方法

本整群随机对照试验于2017年至2022年在越南农村地区的16个社区（8个干预组和8个对照组）进行。纳入了血压未得到控制且同意参与的成年患者（年龄≥18岁）。16个社区按地区分层后被随机分为干预组或对照组。同意参与的成年人按社区分配到研究组。对照组接受了针对卫生工作者的高血压预防和管理培训课程以及患者教育材料。干预组接受了针对卫生工作者的高血压预防和管理培训课程、患者教育材料以及三个强化组分，包括故事讲述干预、家庭血压自我监测和扩大社区卫生工作者服务。主要结局是在12个月的随访期内研究组之间患者收缩压水平变化的差异。患者和结局评估者均处于盲态。

结果

共有671名患者（340名：干预组，331名：对照组）纳入试验。平均年龄为66岁，45%为男性。在12个月的随访时，干预组的平均收缩压下降了18.4 mmHg，对照组下降了3.7 mmHg（差异下降14.7 mmHg [95% CI：11.8 - 17.6]）。干预组在血压控制和药物依从性方面也比对照组更好。没有与参与研究相关的严重不良事件。