An interventional study of Anti-Hypertensive in Hypertension, sponsored by University of Wisconsin, Madison. Completed at 1 site in Guatemala. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research
This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.
An estimated 1.13 billion people worldwide are currently living with hypertension, the leading preventable cause of death and disability. Two thirds of these patients live in low- and middle-income countries (LMIC). Treatment of hypertension has been found to be cost-effective in reducing morbidity and mortality across a broad range of settings. Despite this, less than 10% of patients with hypertension in LMIC have good control of their blood pressure. Health systems in LMIC, which are often focused on providing episodic care for acute illnesses and suffer from inadequate and poorly distributed health care infrastructure and workforce, are ill-equipped to address the rise in chronic non-communicable diseases (NCDs) such as hypertension. Governments and NGOs are increasingly turning to community health workers (CHWs) - lay people trained to carry out a variety of tasks and who often are from or have a close connection to the communities they serve - to help fill care gaps for hypertension and other NCDs in LMIC. In most cases, CHWs have played supportive (e.g. providing patient education) rather than direct care roles. While such programs have led to improved chronic disease outcomes, they still rely on clinic-based physicians, mid-level providers or nurses to directly provide medical management, and therefore do not address the essential problem of inadequate primary care infrastructure and workforce, particularly in rural areas. Overcoming this problem is key to reducing the growing burden of untreated hypertension in LMIC.
To solve this problem, the investigators are developing an innovative mobile application to assist CHWs in the treatment of hypertension in adults with remote physician supervision. This application is built on the widely-used CommCare platform and will provide 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 investigators will develop and test this approach in a rural area of Guatemala with poor primary care infrastructure and where the team has worked extensively in the past and has an ongoing collaboration with a local NGO, the San Lucas Mission, and affiliated CHWs. Through this collaboration, the investigators have developed and implemented a CHW-led rural diabetes program enabled by a CDS mobile application and have demonstrated that CHWs can safely and effectively manage diabetes using the application. The hypothesis is that the investigators will be able to adapt the model to hypertension management and are evaluating the feasibility of this approach with this pilot study.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 32 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
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Exclusion Criteria:
Based on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension.
Change in Systolic Blood Pressure
Difference in systolic blood pressure from baseline to 6 months
Time frame: baseline, 6 months
Difference in Diastolic Blood Pressure From Baseline to 6 Months
Difference in diastolic blood pressure from baseline to 6 months
Time frame: baseline, 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140
Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months
Time frame: baseline, 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal
Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months
Time frame: baseline, 6 months
Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application
This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application.
Time frame: 6 months
| Milestone | Study Participants |
|---|---|
| Started | 32 |
| Completed | 30 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Difference in systolic blood pressure from baseline to 6 months
| mmHg | Study Participants |
|---|---|
| Change in Systolic Blood Pressure | -7.5 (-12.0 to -1.0) |
Difference in diastolic blood pressure from baseline to 6 months
| mmHg | Study Participants |
|---|---|
| Difference in Diastolic Blood Pressure From Baseline to 6 Months | -3.1 (-6.1 to -0.1) |
Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months
| Participants | Study Participants |
|---|---|
| Baseline systolic blood pressure control — Systolic blood pressure controlled (<=140 mmHg) | 21 |
| Baseline systolic blood pressure control — Systolic blood pressure not controlled (>140 mmHg) | 9 |
| Six month systolic blood pressure control — Systolic blood pressure controlled (<=140 mmHg) | 23 |
| Six month systolic blood pressure control — Systolic blood pressure not controlled (>140 mmHg) | 7 |
Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months
| Participants | Study Participants |
|---|---|
| Baseline — Systolic blood pressure less than or equal to personalized goal | 21 |
| Baseline — Systolic blood pressure greater than personalized goal | 9 |
| Six months — Systolic blood pressure less than or equal to personalized goal | 23 |
| Six months — Systolic blood pressure greater than personalized goal | 7 |
This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application.
| Patient visits | Study Participants |
|---|---|
| Visits for which both CHW and physician agreed with medication recommendations | 202 |
| Visits for which either the CHW or physician disagreed with medication recommendations | 7 |
Collected over Six months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/32 (0%) | 0/32 (0%) | 16/32 (50%) |
| Event | Study Participants |
|---|---|
| DyspepsiaGastrointestinal disorders | 5/32 |
| Non-cardiac chest painGeneral disorders | 4/32 |
| HyperglycemiaMetabolism and nutrition disorders | 2/32 |
| DizzinessNervous system disorders | 2/32 |
| HypotensionVascular disorders | 2/32 |
| Alanine aminotransferase increasedInvestigations | 1/32 |
| HeadacheNervous system disorders | 1/32 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 1/32 |
| NauseaGastrointestinal disorders | 1/32 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 1/32 |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 59.0 ± 12.9 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 27 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 32 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 32 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Study Participants |
|---|---|
| Guatemala | 32 |
| Systolic blood pressure(mmHg) | Study Participants |
|---|---|
| Median | 132.0 (124.8 to 143.5) |
| Diastolic blood pressure(mmHg) | Study Participants |
|---|---|
| Mean | 80.8 ± 11.0 |
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