A Phase 3 interventional study of Team-based Care to Implement Single-Pill Combination Therapy and Enhanced Usual Care in Hypertension and Blood Pressure, sponsored by Tulane University. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Tulane University · Phase 3, Interventional, and Treatment
The CATCH cluster randomized trial will test the effectiveness and implementation outcomes of implementing and scaling up the 2017 American Heart Association and 2021 World Health Organization hypertension guidelines through a team-based care approach for blood pressure control in Colombia and Jamaica.
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 to implement a single-pill combination 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,706 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 1, 2026. See what changed
Inclusion criteria for clinics:
Inclusion criteria for participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The core component of the intervention is a single-pill combination therapy recommended by 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 single-pill combination therapy in all intervention clinics. Team-based care components will include 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 to Implement Single-Pill Combination Therapy
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
The core component of the intervention is single-pill combination recommended by 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 health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence.
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.
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
Time frame: 18 months
Difference in blood pressure control (<130/80 mm Hg)
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
Time frame: 18 months
Net difference in mean change of diastolic blood pressure
Differences in mean change of diastolic BP from baseline to 18 months between intervention and control groups
Time frame: 18 months
Side effects
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.
Time frame: 18 months
Health-related quality of life
Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups
Time frame: 18 months
Cost-effectiveness
Incremental direct costs per additional percentage of hypertension control
Time frame: 18 months
Acceptability
Measured by validated survey
Time frame: 18 months
Adoption
Defined as % of clinics adopting intervention components
Time frame: Baseline
Appropriateness
Measured by validated survey
Time frame: 18 months
Feasibility (suitability)
Measured by validated survey
Time frame: Baseline
Fidelity
% of each intervention component delivered per protocol
Time frame: 18 months
Implementation Costs
Defined as all costs associated with implementation and assessed from administrative data
Time frame: 18 months
Penetrance
Defined as % of providers using the intervention approach
Time frame: 18 months
Sustainability
% of clinics maintaining intervention
Time frame: 18 months
Plan to share: Yes — Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study data manager/biostatistician and sent to the Program Official for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
Supporting information: Study protocol, Statistical analysis plan
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.
Data sharing details ↗ · www.catch-study.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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