Mobile Health Intervention for Active Tuberculosis

NCT03544476 | Completed Results

• 2 other identifiers: STUDY00002080K23NR017210
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; Adherence, Medication

Keywords

mobile Health

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Success

  Treatment outcomes will be measured using standard definitions set by the World Health Organization (WHO) Standards of TB treatment. Treatment success based on WHO definitions: completed (without bacteriological confirmation) or cured (negative sputum smear at 6 months and at least once prior to 6 months)). Other treatment outcomes include: failed (sputum smear positive at 5 months or later), died, defaulted (treatment interruption for ≥ 2 months), lost to follow-up (diagnosed, treatment outcome not documented), or transferred out (transferred to another reporting unit and treatment outcome is unknown).

  6 months

Secondary Outcomes (1)

• Engagement: Average Number of Days Participants Reported Through the App

  6 months

Other Outcomes (1)

• Feasibility of Implementation

  6 months

Study Arms (2)

Mobile phone TB treatment support app

EXPERIMENTAL

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).

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

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Interventions

Mobile phone TB treatment support app plus usual care BEHAVIORAL

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.

Mobile phone TB treatment support app

Usual care OTHER

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.

Mobile phone TB treatment support app; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Hospital Dr. Antonio A. Cetrángolo

Vicente López, Province of Buenos Aires, 1602, Argentina

Location

MeSH Terms

Conditions

Tuberculosis; Medication Adherence

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Sarah Iribarren
• Organization: University of Washington

sjiribar@uw.edu

2065435211

Study Officials

• Sarah Iribarren, PhD, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Biobehavioral Nursing and Health Informatics

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: April 9, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 26, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-03

Locations

AR (1)