Community Health Worker-led Hypertension Management

NCT06444308 | Recruiting

• 4 other identifiers: 2024-0566A532050Protocol Version 1/12/264R33TW011891-03
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

community health worker

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP)

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

Secondary Outcomes (24)

• Proportion of Participants with SBP less than 140mmHg

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

• Proportion of Participants with SBP less than their personalized goal

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

• Change in Diastolic Blood Pressure (DBP)

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

• Change in Hemoglobin A1c (HbA1c)

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

• Change in Diabetes Control

  Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

Other Outcomes (8)

• Participant retention at 6 and 12 months

  6 months, 12 months

• Proportion of possible study visits completed at 6 and 12 months

  6 months, 12 months

• Mean duration of study visits

  up to 24 months

Study Arms (2)

Community Health Worker Care

EXPERIMENTAL

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.

Other: CommCare with Mobile Clinical Decision Support (CDS) Application; Other: Remote Supervision by Physicians

Physician Care

ACTIVE COMPARATOR

Other: CommCare Application without CDS

Interventions

CommCare Application without CDS OTHER

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.

Physician Care

Remote Supervision by Physicians OTHER

teleconsultation with a supervising physician

Community Health Worker Care

CommCare with Mobile Clinical Decision Support (CDS) Application OTHER

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

Community Health Worker Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Community

San Lucas Tolimán, Guatemala

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Sean Duffy, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Duffy, MD

CONTACT

608-354-7930; sean.duffy@fammed.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized, controlled, non-inferiority trial, each of 15 clusters of geographically grouped communities in the San Lucas Toliman municipality of Guatemala will be randomized to either CHW or physician care

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)