Clinical trial NCT03544476: Mobile Health Intervention for Active Tuberculosis
Official title: Interactive Mobile Health Intervention to Support Patients With Active Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Adherence, Medication
Keywords: mobile Health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-06-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Success
timeFrame: 6 months
Secondary outcomes:
measure: Engagement: Average Number of Days Participants Reported Through the App
timeFrame: 6 months
Other outcomes:
measure: Feasibility of Implementation
timeFrame: 6 months
Locations:
city: Vicente López
country: Argentina
facility: Hospital Dr. Antonio A. Cetrángolo
state: Province Of Buenos Aires
Study officials:
affiliation: University of Washington
name: Sarah Iribarren, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: