Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Fogarty International Center of the National Institute of Health
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years old * Diagnosed with hypertension * Blood pressure greater than or equal to 140/90 mm Hg OR * currently taking antihypertensive medication
Exclusion criteria
* Pregnancy * Severe comorbid condition(s) with life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | baseline, 6 months | Difference in systolic blood pressure from baseline to 6 months |
| Difference in Diastolic Blood Pressure From Baseline to 6 Months | baseline, 6 months | Difference in diastolic blood pressure from baseline to 6 months |
| Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | baseline, 6 months | Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months |
| Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | baseline, 6 months | Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 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 | 6 months | 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. |
Countries
Guatemala
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Participants All study participants were enrolled in a single arm. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 12.9 |
| Diastolic blood pressure | 80.8 mmHg STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 32 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Guatemala | 32 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 5 Participants |
| Systolic blood pressure | 132.0 mmHg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 16 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Change in Systolic Blood Pressure
Difference in systolic blood pressure from baseline to 6 months
Time frame: baseline, 6 months
Population: All participants who completed the 6 month follow-up visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Participants | Change in Systolic Blood Pressure | -7.5 mmHg |
Comparison: The null hypothesis was that there was no change in systolic blood pressure.p-value: 0.0323295% CI: [-12, -1]Wilcoxon signed rank test
Primary
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
Population: Study participants who completed the 6 month visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Baseline systolic blood pressure control | Systolic blood pressure controlled (<=140 mmHg) | 21 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Baseline systolic blood pressure control | Systolic blood pressure not controlled (>140 mmHg) | 9 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Six month systolic blood pressure control | Systolic blood pressure controlled (<=140 mmHg) | 23 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 | Six month systolic blood pressure control | Systolic blood pressure not controlled (>140 mmHg) | 7 Participants |
Comparison: The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.p-value: 0.7237McNemar
Primary
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
Population: Participants who completed the 6 month visit. Note that this outcome is the same as outcome #3 (change in proportion of patients with systolic blood pressure \<=140 mmHg) because no patients had a personalized goal different than \<=140 mmHg.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Baseline | Systolic blood pressure less than or equal to personalized goal | 21 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Baseline | Systolic blood pressure greater than personalized goal | 9 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Six months | Systolic blood pressure less than or equal to personalized goal | 23 Participants |
| Study Participants | Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal | Six months | Systolic blood pressure greater than personalized goal | 7 Participants |
Comparison: The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.p-value: 0.7237McNemar
Primary
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
Population: Participants who completed the 6 month visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Participants | Difference in Diastolic Blood Pressure From Baseline to 6 Months | -3.1 mmHg |
Comparison: The null hypothesis was that there was no change in diastolic blood pressure.p-value: 0.04595% CI: [-6.1, -0.1]t-test, 2 sided
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Study Participants | 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 | Visits for which both CHW and physician agreed with medication recommendations | 202 Patient visits |
| Study Participants | 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 | Visits for which either the CHW or physician disagreed with medication recommendations | 7 Patient visits |