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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: CommCare with Mobile Clinical Decision Support (CDS) Application; Other: Remote Supervision by Physicians; Other: CommCare Application without CDS

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.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean Duffy, MD; Phone Number: 608-354-7930; Email: sean.duffy@fammed.wisc.edu

Study Locations

• Guatemala
  • San Lucas Tolimán, Guatemala
    • Recruiting
    • Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Worker Care; 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; 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
Active Comparator: Physician Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of lifestyle knowledge questions answered correctly	The proportion of a set of true-false or multiple choice questions developed for this study to assess hypertension-related lifestyle knowledge answered correctly	through study completion, an average of 12 months
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	Indicated by the proportion of diabetic patients with HbA1c less than 8 and the proportion of diabetic patients with HbA1c 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 Weight		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 Total Cholesterol		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 LDL Cholesterol		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 HDL Cholesterol		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 Triglycerides		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 Creatinine		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 Estimated Glomerular Filtration Rate (eGFR)		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 10 year CVD risk (per WHO risk prediction charts)		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 Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score	The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence.	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 H-SCALE: Weight Management Score	The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management.	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 H-SCALE: Physical Exercise Score	The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise.	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 H-SCALE: Smoking Exposure Score	The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure.	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 H-SCALE: Alcohol Intake Score	The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol).	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 H-SCALE: Healthy Eating Plan Score	The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating.	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 selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey	PACIC will be scored on a likert scale from 1-5 (almost never to almost always) where higher scores indicate better assessment of chronic illness care.	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 global hypertension care satisfaction score	Scored from 1-5 where higher scores indicate less satisfaction with hypertension care.	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 pill count adherence ratio (PCAR)	PCAR is the total number of doses dispensed less that total doses missed divided by the total doses dispensed.	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 self-reported adherence	Self-reported adherence is rated on a five point scale of how often patients are taking their medications as directed, from "less than half the time" to "100% of the time".	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 Outcome Measures

Outcome Measure	Time Frame
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
Mean duration of physician review and care coordination time per patient encounter	up to 24 months
Comparison of antihypertensive medications prescribed and dosages	up to 24 months
Proportion of patients with an indication taking aspirin	up to 24 months
Proportion of patients taking two or more antihypertensives	up to 24 months
Estimated cost of care	up to 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Sean Duffy, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: community health worker
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Technology, Industry, and Agriculture; Technology; Audiovisual Aids; Educational Technology; Television; Videodisc Recording; Optical Storage Devices; Compact Disks
• Other Study ID Numbers: 2024-0566; A532050 (Other Identifier: UW Madison); 4R33TW011891-03 (U.S. NIH Grant/Contract); Protocol Version 1/12/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No