HypertensionNCT06444308
Community Health Worker-led Hypertension Management
A study testing CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians and CommCare Application without CDS in people with Hypertension, run by University of Wisconsin, Madison at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians and CommCare Application without CDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteGuatemala
- Study dates
- 9 Sep 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Severe comorbid condition(s) with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians, CommCare Application without CDS
- Keywords
- community health worker
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommCare with Mobile Clinical Decision Support (CDS) ApplicationOther
For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
Remote Supervision by PhysiciansOther
teleconsultation with a supervising physician
CommCare Application without CDSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CommCare with Mobile Clinical Decision Support (CDS) Application; Other: Remote Supervision by Physicians |
| Physician Care | Active comparator | Not described Receives: Other: CommCare Application without CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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 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
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start9 Sep 2024
- Primary completion30 Sep 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Sean Duffy, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444308
- Sponsor's protocol ID
- 2024-0566
- Other IDs
- A532050, Protocol Version 1/12/26, 4R33TW011891-03
- Status last verified
- Oct 2026
- First submitted
- 30 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06444308
- Acronym / sponsor ID
- 2024-0566
- Conditions
- Hypertension
- Keywords
- community health worker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 449 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Care | Experimental | Other: CommCare with Mobile Clinical Decision Support (CDS) Application, Other: Remote Supervision by PhysiciansMultimodal 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. |
| Physician Care | Active comparator | Other: CommCare Application without CDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Severe comorbid condition(s) with life expectancy less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommCare with Mobile Clinical Decision Support (CDS) ApplicationFor those assigned to the CHW arm, management will be assisted by CDS from the CommCare application. | Other | Community Health Worker Care |
| Remote Supervision by Physiciansteleconsultation with a supervising physician | Other | Community Health Worker Care |
| CommCare Application without CDSThe 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. | Other | Physician Care |
Primary outcome
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)
24 secondary outcomes
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)
Change in 10 year CVD risk (per WHO risk prediction charts)
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 Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score
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 H-SCALE: Weight Management Score
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 H-SCALE: Physical Exercise Score
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 H-SCALE: Smoking Exposure Score
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 H-SCALE: Alcohol Intake Score
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 H-SCALE: Healthy Eating Plan Score
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 selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey
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 global hypertension care satisfaction score
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 pill count adherence ratio (PCAR)
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 self-reported adherence
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 lifestyle knowledge questions answered correctly
Time frame: through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Duffy, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians and CommCare Application without CDS in people with Hypertension, run by University of Wisconsin, Madison at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.