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Clinical Trials/NCT05405920
NCT05405920
Active, not recruiting
Not Applicable

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

Tulane University2 sites in 2 countries1,280 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Tulane University
Enrollment
1280
Locations
2
Primary Endpoint
Net difference in mean change of systolic blood pressure
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
August 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jiang He, MD, PhD

Professor and Chair

Tulane University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Net difference in mean change of systolic blood pressure

Time Frame: 18 months

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

Secondary Outcomes

  • 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)

Study Sites (2)

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