Caribbean and South America Team-based Strategy to Control Hypertension

NCT05405920 | Active Not Recruiting DMC

• 1 other identifier: UG3HL152373
• Study Type: interventional
• Target: 1,280
• Locations: 2 countries
• Sites: 2

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.

Conditions

Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Net difference in mean change of systolic blood pressure

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

  18 months

Secondary Outcomes (5)

• Difference in blood pressure control (<130/80 mm Hg)

  18 months

• Net difference in mean change of diastolic blood pressure

  18 months

• Side effects

  18 months

• Health-related quality of life

  18 months

• Cost-effectiveness

  18 months

Other Outcomes (8)

• Acceptability

  18 months

• Adoption

  Baseline

• Appropriateness

  18 months

Study Arms (2)

Team-based Care Strategy for Hypertension Control

EXPERIMENTAL

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.

Behavioral: Team-based Care Strategy for Hypertension Control

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

Team-based Care Strategy for Hypertension Control BEHAVIORAL

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.

Team-based Care Strategy for Hypertension Control

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Tulane University: lead
• National Institutes of Health (NIH): collaborator
• Universidad de Santander: collaborator
• University of the West Indies, Jamaica: collaborator

Study Sites (2)

20 primary care clinics in Colombia

Santander, Colombia

Location

20 primary care clinics in Jamaica

Kingston, Jamaica

Location

Related Publications (1)

• Mills KT, Ferguson T, Lopez-Lopez JP, Duncan J, Lanza P, Marshall A, Reyes M, Chen J, Anderson AH, Whelton PK, Bailey A, Lindsay C, Sanchez G, Lopez-Jaramillo P, Tulloch-Reid M, He J. Caribbean and South American team-based strategy to control hypertension (CATCH): Rationale and study design of a cluster randomized trial. Am Heart J. 2025 Dec 17;294:107329. doi: 10.1016/j.ahj.2025.107329. Online ahead of print.

  PMID: 41419163 DERIVED

Related Links

• CATCH Study Website

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jiang He, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

• Marshall Tulloch-Reid, MBBS, DSc

  University of the West Indies, Jamaica

  PRINCIPAL INVESTIGATOR

• Patricio López-Jaramillo, MD, PhD

  Universidad de Santander

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: cluster-randomization of 40 primary care clinics

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 6, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: We will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.

Locations

CO (1); JA (1)