Managing hypertension with community health workers in rural Guatemala
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 testing if community health workers using a mobile app can help people in rural Guatemala manage their high blood pressure better than regular doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (San Lucas Tolimán) |
| Trial ID | NCT06444308 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether community health workers (CHWs), supported by a mobile health application and remote physician supervision, can effectively manage hypertension compared to traditional physician-led care. The innovative care model utilizes a mobile application that provides clinical decision support based on established protocols for hypertension management. The study will take place over 12-24 months in rural Guatemala, focusing on improving systolic blood pressure in patients diagnosed with hypertension. The research aims to assess not only the effectiveness of this approach but also its safety, patient acceptability, and cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of hypertension and a blood pressure of 140/90 or higher, or those currently on antihypertensive medication.
Not a fit: Patients who are pregnant or have severe comorbid conditions with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide accessible and effective hypertension management in underserved rural populations.
How similar studies have performed: Previous studies utilizing community health workers for chronic disease management have shown success, indicating potential for this approach in hypertension management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Lucas Tolimán
- Community — San Lucas Tolimán, Guatemala (Recruiting)
Study contacts
- Principal investigator: Sean Duffy, MD — University of Wisconsin, Madison
- Study coordinator: Sean Duffy, MD
- Email: sean.duffy@fammed.wisc.edu
- Phone: 608-354-7930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.