Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage

Study Overview
=================
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.

Official Title
-----------------
A Feasibility Study of a Novel mHealth Clinical Decision Support Application to Enable Community Health Workers to Manage Hypertension With Remote Physician Supervision

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Anti-Hypertensive


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anti-Hypertensive|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure | Difference in systolic blood pressure from baseline to 6 months | baseline, 6 months | 
| Difference in diastolic blood pressure from baseline to 6 months | Difference in diastolic blood pressure from baseline to 6 months | 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 | 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 | 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. | Up to 12 months |