NCT06444308

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. 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

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-09
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-06-05
• Last updated: 2026-01-28

Locations

1 site across 1 country: Guatemala