NCT03544476

Mobile Health Intervention for Active Tuberculosis

Interactive Mobile Health Intervention to Support Patients With Active Tuberculosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and further refine a mobile support tool for patients receiving treatment for active tuberculosis. Half of participants will receive support and monitoring using a mobile phone software application and usual care, while the other half will receive usual care.

Detailed description

Tuberculosis (TB) remains a top ten leading cause of death globally despite it being a largely curable disease. New effective treatment supervision strategies are needed particularly in low-resource high TB burden settings and a potential solution is in the hands of nearly every patient - a mobile phone. Modern modular design mobile phone software applications ("apps") hold great promise to address this unmet need. Current technologies allows for rapid design modification based on end user needs, implementation of native operating system (e.g., Android) versions for users with inconsistent internet access, and the integration of the patients' experiences with electronic health records using industry standards. Apps can perform multiple functions (e.g., automated reminders, symptom tracking, secure messaging, multi-media education). To date, few TB related apps have focused on patients as users, and none support patient engagement in self-management of their care or direct adherence monitoring. The research objectives are to understand end user needs and other stakeholder needs to build, refine, and pilot test an app to support patients self-administering treatment for active TB.

Conditions

• Tuberculosis
• Adherence, Medication

Interventions

Type	Name	Description
BEHAVIORAL	Mobile phone TB treatment support app plus usual care	The behavioral intervention is delivered through a mobile phone TB support app. The functions allow the participant to: self-report daily administration of their TB medication, self-report side effects if applicable, review educational material on TB disease and its treatment, complete a treatment adherence monitoring test (urine drug metabolite test), take notes, and review their treatment progress/report. The drug metabolite test will require that the participant place a small amount of urine on the end of the paper strip, wait for results, and take a picture of the paper using the app. The purpose of this test is to confirm that medication was correctly taken within the past 24 hours.
OTHER	Usual care	Usual care consists of outpatient treatment management from the time of diagnosis (unless symptoms are severe and hospitalization is recommended), routine clinical and laboratory tests, and follow-up appointments determined by the clinician. In general, patients receive 1-2 month's supply of medication and are asked to return monthly for follow-up.

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-03-31
• Completion: 2020-07-31
• First posted: 2018-06-01
• Last updated: 2025-03-26
• Results posted: 2025-03-10

Locations

1 site across 1 country: Argentina