Mobile Health Intervention for Active Tuberculosis

University of Washington

Status: Completed

Conditions: Tuberculosis; Adherence, Medication

Treatments: Behavioral: Mobile phone TB treatment support app plus usual care; Other: Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03544476

K23NR017210 (U.S. NIH Grant/Contract)

STUDY00002080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is starting TB treatment for the first time
• Subject has no known TB drug resistance
• Subject is HIV negative (self-reported or documented)
• Subject owns or has regular access to a mobile phone that can access the Internet and is able to operate the mobile phone to communicate or have someone able to assist.

Exclusion criteria

• Severely ill (i.e., requiring hospitalization)
• Reside in the same household with another study participant
• History of known drug resistance and HIV co-infection because their care is managed separately and the treatment regimens and duration differ.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Mobile phone TB treatment support app

Experimental group

Description:

Daily use of the mobile phone TB treatment support app plus usual care. Participants will be asked to self-report daily TB medication administration, side-effects when applicable, and complete the direct adherence paper-based test randomly on 3-4 days of the week during the intensive treatment phase (first two months) and then 1-2 times per week during the maintenance phase (about month 3-6).

Treatment:

Other: Usual care

Behavioral: Mobile phone TB treatment support app plus usual care

Usual care

Active Comparator group

Description:

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.

Treatment:

Other: Usual care