Community Health Worker-led Hypertension Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians, CommCare Application without CDS.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guatemala
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Change in Systolic Blood Pressure (SBP) [Time frame: 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 (12)
- Proportion of Participants with SBP less than 140mmHg [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Guatemala · 1 center
- Community — San Lucas Tolimán
Identifiers
NCT: NCT06444308 · 2024-0566 · A532050 · Protocol Version 1/12/26 · 4R33TW011891-03