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Community Health Worker-led Hypertension Management

NCT06444308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-01-28

No results posted yet for this study

Summary

This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.

Conditions

Interventions

OTHER

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.

OTHER

Remote Supervision by Physicians

teleconsultation with a supervising physician

OTHER

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.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Sean Duffy, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Guatemala

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444308 on ClinicalTrials.gov