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

July 11, 2024 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
    • Sololá
      • San Lucas Tolimán, Sololá, Guatemala, 07013
        • San Lucas Mission

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: baseline, 6 months
Difference in systolic blood pressure from baseline to 6 months
baseline, 6 months
Difference in Diastolic Blood Pressure From Baseline to 6 Months
Time Frame: baseline, 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
Time Frame: baseline, 6 months
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
Time Frame: 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
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
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Sean Duffy, MD, University of Wisconsin-Madison Department of Family Medicine and Community Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0794
  • A532050 (Other Identifier: UW Madison)
  • Approval Date 7/2/2022 (Other Identifier: UW Madison)
  • 1R21TW011891-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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