Community Health Worker-led Hypertension Management

University of Wisconsin (UW)

Status: Enrolling

Conditions: Hypertension

Treatments: Other: CommCare Application without CDS; Other: Remote Supervision by Physicians; Other: CommCare with Mobile Clinical Decision Support (CDS) Application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06444308

A532050 (Other Identifier)

Protocol Version 1/26/25 (Other Identifier)

4R33TW011891-03 (U.S. NIH Grant/Contract)

2024-0566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Community Health Worker Care

Experimental group

Description:

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.

Treatment:

Other: CommCare with Mobile Clinical Decision Support (CDS) Application

Other: Remote Supervision by Physicians

Physician Care

Active Comparator group

Treatment:

Other: CommCare Application without CDS