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Active, Not Recruiting

NCT Number: NCT05405920

Caribbean and South America Team-based Strategy to Control Hypertension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

20 primary care clinics in Colombia, Santander, Colombia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

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

    Time frame: 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

  2. Net difference in mean change of diastolic blood pressure

    Time frame: 18 months

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

  3. Side effects

    Time frame: 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.

  4. Health-related quality of life

    Time frame: 18 months

    Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups

  5. Cost-effectiveness

    Time frame: 18 months

    Incremental direct costs per additional percentage of hypertension control

Other outcomes

  1. Acceptability

    Time frame: 18 months

    Measured by validated survey

  2. Adoption

    Time frame: Baseline

    Defined as % of clinics adopting intervention components

  3. Appropriateness

    Time frame: 18 months

    Measured by validated survey

  4. Feasibility (suitability)

    Time frame: Baseline

    Measured by validated survey

  5. Fidelity

    Time frame: 18 months

    % of each intervention component delivered per protocol

  6. Implementation Costs

    Time frame: 18 months

    Defined as all costs associated with implementation and assessed from administrative data

  7. Penetrance

    Time frame: 18 months

    Defined as % of providers using the intervention approach

  8. Sustainability

    Time frame: 18 months

    % of clinics maintaining intervention

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CATCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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