Caribbean and South America Team-based Strategy to Control Hypertension

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Blood Pressure
• Interventions: Behavioral: Team-based Care Strategy for Hypertension Control; Behavioral: Enhanced Usual Care

• Registration Number: NCT05405920
• Lead Sponsor: Tulane University

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.

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2023-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Team-based Care Strategy for Hypertension Control	Team-based Care Strategy for Hypertension Control	The core component of the intervention is a stepped-care protocol, based on 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 task sharing and shifting, health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence.
Enhanced Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Net difference in mean change of systolic blood pressure	18 months	Differences in mean change of systolic BP from baseline to 18 months between intervention and control groups

Secondary Outcome Measures

Name	Time	Method
Difference in blood pressure control (<130/80 mm Hg)	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
Side effects	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.
Health-related quality of life	18 months	Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups
Net difference in mean change of diastolic blood pressure	18 months	Differences in mean change of diastolic BP from baseline to 18 months between intervention and control groups
Cost-effectiveness	18 months	Incremental direct costs per additional percentage of hypertension control

Trial Locations

Locations (2)

20 primary care clinics in Colombia; 🇨🇴 Santander, Colombia

20 primary care clinics in Jamaica; 🇯🇲 Kingston, Jamaica