Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
460 participants
INTERVENTIONAL
2024-09-09
2026-09-30
Brief Summary
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Detailed Description
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The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.
The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Community Health Worker Care
Multimodal health systems intervention: hypertension management by trained CHWs equipped with a mobile clinical decision support (CDS) application and remote supervision and support by physicians. CHWs will meet with patients each month and, with the assistance of the CDS application, follow physician-approved and evidence-based protocols to initiate and titrate antihypertensives and medications to reduce cardiovascular risk; identify potential complications of hypertension or problems with medications; and provide lifestyle counseling. For patients with comorbid hypertension and diabetes, CHWs will also manage glycemic therapy and assess for diabetes complications with the assistance of the application.
CommCare with Mobile Clinical Decision Support (CDS) Application
For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
Remote Supervision by Physicians
teleconsultation with a supervising physician
Physician Care
CommCare Application without CDS
The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only.
Interventions
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CommCare with Mobile Clinical Decision Support (CDS) Application
For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
Remote Supervision by Physicians
teleconsultation with a supervising physician
CommCare Application without CDS
The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
Exclusion Criteria
* Severe comorbid condition(s) with life expectancy less than 1 year
18 Years
ALL
No
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Sean Duffy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Community
San Lucas Tolimán, , Guatemala
Countries
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Central Contacts
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Other Identifiers
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A532050
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 8/27/25
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0566
Identifier Type: -
Identifier Source: org_study_id
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