Community Health Worker-led Hypertension Management

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06444308
• Lead Sponsor: University of Wisconsin, Madison

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.

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 Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Study Start: 2024-09-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants with SBP less than 140mmHg	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Proportion of Participants with SBP less than their personalized goal	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Total Cholesterol	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Estimated Glomerular Filtration Rate (eGFR)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in 10 year CVD risk (per WHO risk prediction charts)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in H-SCALE: Weight Management Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management.
Change in H-SCALE: Physical Exercise Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise.
Change in H-SCALE: Smoking Exposure Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure.
Change in H-SCALE: Alcohol Intake Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol).
Change in self-reported adherence	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	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".
Change in Diabetes Control	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	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.
Change in Weight	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in LDL Cholesterol	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in HDL Cholesterol	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Triglycerides	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Creatinine	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence.
Change in H-SCALE: Healthy Eating Plan Score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating.
Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	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.
Change in Diastolic Blood Pressure (DBP)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in Hemoglobin A1c (HbA1c)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Change in global hypertension care satisfaction score	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	Scored from 1-5 where higher scores indicate less satisfaction with hypertension care.
Change in pill count adherence ratio (PCAR)	Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)	PCAR is the total number of doses dispensed less that total doses missed divided by the total doses dispensed.
Proportion of lifestyle knowledge questions answered correctly	through study completion, an average of 12 months	The proportion of a set of true-false or multiple choice questions developed for this study to assess hypertension-related lifestyle knowledge answered correctly

Trial Locations

Locations (1)

Community; 🇬🇹 San Lucas Tolimán, Guatemala