Caribbean and South American team-based strategy to control hypertension (CATCH): Rationale and study design of a cluster randomized trial

IF 3.4 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2026-04-01 Epub Date: 2025-12-17 DOI:10.1016/j.ahj.2025.107329

Katherine T. Mills PhD , Trevor Ferguson DM, PhD , Jose P. Lopez-Lopez MD , Jacqueline Duncan MD, MPH , Paola Lanza MD , Allison Marshall PhD , Mabel Reyes , Jing Chen MD , Amanda H. Anderson PhD , Paul K. Whelton MD, MSc , Althea Bailey PhD , Carene Lindsay MSc , Gregorio Sanchez MD , Patricio Lopez-Jaramillo MD, PhD , Marshall Tulloch-Reid MD, DSc , Jiang He MD, PhD

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引用次数: 0

Abstract

Rationale

Hypertension disproportionately affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean, due to its high prevalence and low control rate.

Primary Hypothesis

To close the knowledge-practice gap for blood pressure (BP) control, we are assessing the effectiveness and implementation of a team-based care strategy for BP control in primary care clinics in Colombia and Jamaica.

Design

The Caribbean and South American Team-based Strategy to Control Hypertension (CATCH) study is a cluster randomized trial using an effectiveness–implementation hybrid type-2 design. Clinics were randomly assigned to a team-based strategy or a provider-training strategy to implement current hypertension guidelines. The team-based strategy includes healthcare team training, care coordination, task sharing, BP audit and feedback, home BP monitoring, health coaching, single-pill combination therapy, and increased medication access. The primary clinical effectiveness outcome is difference in mean change of systolic BP from baseline to 18 months between randomized groups. The primary implementation outcome is a composite fidelity score to key implementation strategy components.

Sites

CATCH is conducted in 40 primary care clinics in Jamaica and Colombia.

Enrollment

Between February 2023 and August 2024, we recruited 1,707 participants, exceeding our planned enrollment. The planned sample size of 1,680 (42 patients per each of 40 clinics) has 90% statistical power to detect a 6.0 mm Hg difference in mean systolic BP change assuming 85% follow-up and a 2-sided significance level of 0.05.

Current Status

In follow-up

Conclusions

CATCH will provide evidence on effectiveness and implementation of a team-based care strategy to improve hypertension control in real-world, primary care settings. If proven effective, this approach can be scaled up in primary care throughout low- and middle-income countries (LMICs).

Clinical Trial Registration

Clinicaltrials.gov, NCT05405920

https://clinicaltrials.gov/study/ NCT05405920.

查看原文本刊更多论文

加勒比海和南美洲以团队为基础的高血压控制策略（CATCH）：一项聚类随机试验的基本原理和研究设计。

理由：由于高血压的高患病率和低控制率，它对低收入和中等收入国家（LMICs）人群的影响格外严重，尤其是在拉丁美洲和加勒比地区。主要假设：为了缩小血压控制的知识与实践差距，我们正在评估哥伦比亚和牙买加初级保健诊所中以团队为基础的血压控制护理策略的有效性和实施情况。设计：加勒比和南美以团队为基础的高血压控制策略（CATCH）研究是一项采用有效性-实施混合型2型设计的聚类随机试验。诊所被随机分配到以团队为基础的策略或提供者培训策略，以实施当前的高血压指南。基于团队的策略包括医疗团队培训、护理协调、任务共享、血压审计和反馈、家庭血压监测、健康指导、单片联合治疗和增加药物获取。主要临床疗效指标是随机分组之间从基线到18个月的平均收缩压变化的差异。主要的实现结果是对关键实现策略组件的复合保真度评分。地点：CATCH在牙买加和哥伦比亚的40个初级保健诊所开展。招募：在2023年2月至2024年8月期间，我们招募了1707名参与者，超过了我们的计划招募人数。计划样本量为1680例（40家诊所每家42例患者），假设随访率为85%，双侧显著性水平为0.05，有90%的统计能力检测到平均收缩压变化6.0 mm Hg的差异。结论：CATCH将提供基于团队的护理策略的有效性和实施的证据，以改善现实世界初级保健环境中的高血压控制。如果证明有效，这种方法可以在整个中低收入国家的初级保健中推广。试验注册：Clinicaltrials.gov, NCT05405920 https://clinicaltrials.gov/study/NCT05405920。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.