HypertensionPhase 3CATCHNCT05405920
Caribbean and South America Team-based Strategy to Control Hypertension
A Phase 3 study testing Team-based Care to Implement Single-Pill Combination Therapy in people with Hypertension and Blood Pressure, run by Tulane University at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- Team-based Care to Implement Single-Pill Combination Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,706 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Feb 2023to 9 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- No prior hospitalization for heart failure
Show all 11Show fewer
- No stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate <30 ml/min/1,73m2, chronic dialysis, or transplant)
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica
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.
Read the 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 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.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- Team-based Care to Implement Single-Pill Combination Therapy, Enhanced Usual Care
- Keywords
- Single-pill combination, Team-based care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-based Care to Implement Single-Pill Combination TherapyBehavioural
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.
Enhanced Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementing Single-pill Combination by Team-based Care | Experimental | 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. Receives: Behavioral: Team-based Care to Implement Single-Pill Combination Therapy |
| 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 18 months
Cost-effectiveness
Incremental direct costs per additional percentage of hypertension control
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start23 Feb 2023
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Implementing single-pill combination therapy through a team-based care approach
- Masking
- None (open label)
- Enrolment
- 1,706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Universidad de Santander, The University of The West Indies
- Responsible party
- Principal investigator, Jiang He, MD, PhD, Tulane University
- Investigators
- Jiang He, MD, PhD, Principal investigator, Tulane UniversityMarshall Tulloch-Reid, MBBS, DSc, Principal investigator, The University of The West IndiesPatricio López-Jaramillo, MD, PhD, Principal investigator, Universidad de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405920
- Sponsor's protocol ID
- UG3HL152373
- Acronym
- CATCH
- Status last verified
- Sep 2026
- First submitted
- 27 May 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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. 2026 Apr;294:107329. doi: 10.1016/j.ahj.2025.107329. Epub 2025 Dec 17.
PubMed 41419163
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica
- ClinicalTrials.gov ID
- NCT05405920
- Acronym / sponsor ID
- CATCH / UG3HL152373
- Conditions
- Hypertension, Blood Pressure
- Keywords
- Single-pill combination, Team-based care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Universidad de Santander, The University of The West Indies
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Implementing single-pill combination therapy through a team-based care approach
| Arm | Type | Receives |
|---|---|---|
| Implementing Single-pill Combination by Team-based Care | Experimental | Behavioral: Team-based Care to Implement Single-Pill Combination TherapyThe 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-based Care to Implement Single-Pill Combination TherapyThe 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. | Behavioural | Implementing Single-pill Combination by Team-based Care |
| Enhanced Usual CareWe 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. | Behavioural | Enhanced Usual Care |
Primary outcome
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
5 secondary outcomes
Difference in blood pressure control (<130/80 mm Hg)
Time frame: 18 months
Net difference in mean change of diastolic blood pressure
Time frame: 18 months
Side effects
Time frame: 18 months
Health-related quality of life
Time frame: 18 months
Cost-effectiveness
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 41419163Mills 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. 2026 Apr;294:107329. doi: 10.1016/j.ahj.2025.107329. Epub 2025 Dec 17.
- CATCH Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang He, MD, PhD principal investigator
Tulane University
Marshall Tulloch-Reid, MBBS, DSc principal investigator
The University of The West Indies
Patricio López-Jaramillo, MD, PhD principal investigator
Universidad de Santander
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Team-based Care to Implement Single-Pill Combination Therapy in people with Hypertension and Blood Pressure, run by Tulane University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia, Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net difference in mean change of systolic blood pressure (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.