RecruitingNot ApplicableNCT06444308

Community Health Worker-led Hypertension Management

Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial


Sponsor

University of Wisconsin, Madison

Enrollment

460 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140/90 OR currently taking antihypertensive medication.
  • Ability to provide informed consent

Exclusion Criteria2

  • Pregnancy
  • Severe comorbid condition(s) with life expectancy less than 1 year

Interventions

OTHERCommCare with Mobile Clinical Decision Support (CDS) Application

For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.

OTHERRemote Supervision by Physicians

teleconsultation with a supervising physician

OTHERCommCare 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.


Locations(1)

Community

San Lucas Tolimán, Guatemala

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NCT06444308


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