Mobile Health Intervention for Active Tuberculosis

• ClinicalTrials.gov Identifier: NCT03544476
• Recruitment Status: Completed
• First Posted: June 1, 2018
• Last Update Posted: December 10, 2020
• Sponsor: University of Washington
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Sarah Iribarren, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tuberculosis; Adherence, Medication	Behavioral: Mobile phone TB treatment support app plus usual care; Other: Usual care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Interactive Mobile Health Intervention to Support Patients With Active Tuberculosis
• Actual Study Start Date: April 9, 2019
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: July 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mobile phone TB treatment support app; 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; 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Acceptability (perceived usefulness and ease of use) [ Time Frame: 6 months ]
   The Mobile Application Rating Scale (MARS) is a 19-item. The scale includes three sections and a modifiable app-specific section: classification, quality and satisfaction classification section provides descriptive information about the apps. The objective app quality section includes 19-items divided into four scales: engagement, functionality, aesthetics and information quality. The subjective quality section contains 4 items evaluating the user's overall satisfaction. MARS items are scored using a 5-point Likert scale. The final MARS scores include four subscale scores, a total mean score, subjective quality score and an app-specific subscale that assesses perceived impact on the user's knowledge, attitudes, and intentions to change as well as likelihood of changing targeted behaviors.
2. Feasibility of implementation [ Time Frame: 6 months ]
   Semi-structured interview with participants to understand challenges, recommendations for improvement. Observations
3. Initial efficacy - Treatment outcome [ Time Frame: 6 months ]
   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).

Secondary Outcome Measures :

1. Global Health Patient-Reported Outcomes Measurement Information System (PROMIS) short form [ Time Frame: day 1 and 6 months ]
   The Global Health short form (SF) is a recommended outcome measure for self-management, includes 10 items
2. Tuberculosis Knowledge Assessment Questionnaire [ Time Frame: day 1 and 6 months ]
   Items include questions focused on exploring knowledge about: causes and symptoms of TB (5 items), TB transmission (4 items), TB treatment (2 items), and TB prevention (5 items). The questions are structured to answer (yes, no, I don't know).
3. Engagement [ Time Frame: 6 months ]
   Level of engagement using the app will be measured by percentage of notification without a reminder, number of questions, number of reported side effects.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Argentina

Hospital Dr. Antonio A. Cetrángolo

Vicente López, Province Of Buenos Aires, Argentina, 1602

Sponsors and Collaborators

University of Washington

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Sarah Iribarren, PhD, RN; University of Washington

More Information

• Responsible Party: Sarah Iribarren, Assistant Professor, Biobehavioral Nursing and Health Informatics, University of Washington
• ClinicalTrials.gov Identifier: NCT03544476
• Other Study ID Numbers: STUDY00002080; K23NR017210 ( U.S. NIH Grant/Contract )
• First Posted: June 1, 2018
• Last Update Posted: December 10, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah Iribarren, University of Washington:

mobile Health

Additional relevant MeSH terms:

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections