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加勒比海和南美洲基于团队的高血压控制策略 (CATCH)

2026年9月28日 更新者：Jiang He, MD, PhD、Tulane University

在哥伦比亚和牙买加实施和扩大基于团队的高血压控制护理策略

The CATCH cluster randomized trial will test the effectiveness and implementation outcomes of implementing and scaling up the 2017 American Heart Association and 2021 World Health Organization hypertension guidelines through a team-based care approach for blood pressure control in Colombia and Jamaica.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The CATCH Study includes a two-year UG3 Planning Phase and a four-year UH3 Implementation Phase. In the UH3 Implementation Phase, we will first conduct a cluster randomized implementation trial to test the effectiveness and implementation of a team-based care strategy to implement a single-pill combination strategy for hypertension control among patients with hypertension in 40 clinics from Colombia and Jamaica (20 in each country). Twenty clinics will be randomized to the team-based care intervention and 20 to provider training intervention. A total of 1,680 patients (42 per clinic) with uncontrolled hypertension will be recruited into the study and followed for 18 months for effectiveness and implementation outcomes. A post-intervention study visit will take place 6 months after the end of the 18-month intervention to evaluate the sustainability of the implementation strategies. We will subsequently conduct a pre- and post- scale-up comparison study to implement the team-based care strategy in all remaining public primary care clinics that provide chronic disease management in Jamaica and primary care clinics in the seven participating departments in Colombia. A pre- and post- scale-up comparison design will be used to assess barriers and implementation outcomes before and 12 months after the scale-up intervention at the clinic, primary care physician, nurse/pharmacist, and community health worker (CHW) levels.

研究类型

介入性

注册 (实际的)

1706

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 哥伦比亚
      • Santander、哥伦比亚
        • 20 primary care clinics in Colombia
  • 牙买加
      • Kingston、牙买加
        • 20 primary care clinics in Jamaica

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria for clinics:

  • Serving >300 hypertensive patients during the previous year
  • Clinic visits and BP medications are free of charge to patients
  • Not sharing physicians, nurses, pharmacists, or community health workers (CHWs) with other clinics

Inclusion criteria for participants:

  • Men or women aged ≥ 21 years who receive primary care from participating clinics
  • Average untreated BP ≥140/90 mm Hg among individuals without a history of clinical cardiovascular disease (CVD), chronic kidney disease (CKD), or diabetes; average untreated BP ≥130/80 mm Hg among individuals aged ≥65 years or those with clinical CVD, CKD, or diabetes; or average treated BP ≥130/80 mm Hg from six BP readings at two screening visits
  • No prior hospitalization for heart failure
  • No stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate <30 ml/min/1,73m2, chronic dialysis, or transplant)
  • Not pregnant or planning to become pregnant in the next 18 months
  • Able and willing to give informed consent
  • No plans to change primary care clinic in the next 18 months
  • Not an immediate family member of staff at the primary care clinic

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Implementing Single-pill Combination by Team-based Care

The core component of the intervention is a single-pill combination therapy recommended by the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Practice Guideline for High Blood Pressure and the 2021 World Health Organization (WHO) Hypertension Guideline. Using a team-based care model, a physician-nurse-CHW team will work with patients to implement single-pill combination therapy in all intervention clinics. Team-based care components will include health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence.
行为的：Team-based Care to Implement Single-Pill Combination Therapy

The core component of the intervention is single-pill combination recommended by the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Practice Guideline for High Blood Pressure and the 2021 World Health Organization (WHO) Hypertension Guideline. Using a team-based care model, a physician-nurse-CHW team will work with patients to implement clinical guideline-based treatment in all intervention clinics. Team-based care components will include health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence.
有源比较器：Enhanced Usual Care

We will train the primary care physicians, nurses, and other clinic staff in performing standardized BP measurements. We will offer physician education on clinical guidelines for hypertension management and issue continuing medical education credits. Patient educational materials will be distributed. We will not conduct any other interventions in the enhanced usual care clinics.
行为的：Enhanced Usual Care

We will train the primary care physicians, nurses, and other clinic staff in performing standardized BP measurements. We will offer physician education on clinical guidelines for hypertension management and issue continuing medical education credits. Patient educational materials will be distributed. We will not conduct any other interventions in the enhanced usual care clinics.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Net difference in mean change of systolic blood pressure
大体时间：18 months

Differences in mean change of systolic BP from baseline to 18 months between intervention and control groups
18 months

次要结果测量

结果测量
措施说明
大体时间
Difference in blood pressure control (<130/80 mm Hg)
大体时间：18 months

Difference in the proportion of patients with systolic BP <130 mm Hg and diastolic BP <80 mm Hg between intervention and control groups at 18 months
18 months
Net difference in mean change of diastolic blood pressure
大体时间：18 months

Differences in mean change of diastolic BP from baseline to 18 months between intervention and control groups
18 months
Side effects
大体时间：18 months

Differences in medication side effects between intervention and control groups will be assessed by survey. A list of common side effects associated with high blood pressure will be asked of participants to collect presence and frequency of side effects.
18 months
Health-related quality of life
大体时间：18 months

Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups
18 months
Cost-effectiveness
大体时间：18 months

Incremental direct costs per additional percentage of hypertension control
18 months

其他结果措施

结果测量
措施说明
大体时间
Acceptability
大体时间：18 months

Measured by validated survey
18 months
Adoption
大体时间：Baseline

Defined as % of clinics adopting intervention components
Baseline
Appropriateness
大体时间：18 months

Measured by validated survey
18 months
Feasibility (suitability)
大体时间：Baseline

Measured by validated survey
Baseline
Fidelity
大体时间：18 months

% of each intervention component delivered per protocol
18 months
Implementation Costs
大体时间：18 months

Defined as all costs associated with implementation and assessed from administrative data
18 months
Penetrance
大体时间：18 months

Defined as % of providers using the intervention approach
18 months
Sustainability
大体时间：18 months

% of clinics maintaining intervention
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tulane University

合作者

National Institutes of Health (NIH)
The University of The West Indies
Universidad de Santander

调查人员

  • 首席研究员：Patricio López-Jaramillo, MD, PhD、Universidad de Santander
  • 首席研究员：Jiang He, MD, PhD、Tulane University
  • 首席研究员：Marshall Tulloch-Reid, MBBS, DSc、The University of The West Indies

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年2月23日

初级完成 (实际的)

2026年9月9日

研究完成 (实际的)

2026年9月9日

研究注册日期

首次提交

2022年5月27日

首先提交符合 QC 标准的

2022年6月1日

首次发布 (实际的)

2022年6月6日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UG3HL152373 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study data manager/biostatistician and sent to the Program Official for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.

IPD 共享时间框架

Data sets will be submitted to the study's NHLBI Program Official no later than 3 years after the end of the final patient follow-up visit or 2 years after the main paper of the trial has been published, whichever comes first.

IPD 共享访问标准

We will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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