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临床试验/NCT05405920
NCT05405920进行中(未招募)不适用

Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica

Tulane University2 个研究点 分布在 2 个国家目标入组 1,280 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,280
试验地点
2
主要终点
Net difference in mean change of systolic blood pressure

研究概览

简要总结

The CATCH cluster randomized trial will test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for blood pressure control in Colombia and Jamaica.

详细描述

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 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Due to the nature of the cluster design and intervention program, the study participants, primary care physicians, nurses, community health workers, and research staff who collected clinical outcome data will not be blinded. The outcome adjudication committee members, however, will be blinded to randomization assignment for adverse event evaluation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Net difference in mean change of systolic blood pressure

时间窗: 18 months

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

次要结局

  • Difference in blood pressure control (<130/80 mm Hg)(18 months)
  • Side effects(18 months)
  • Health-related quality of life(18 months)
  • Net difference in mean change of diastolic blood pressure(18 months)
  • Cost-effectiveness(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiang He, MD, PhD

Professor and Chair

Tulane University

研究点 (2)

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