Mobile Health Intervention for Active Tuberculosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interactive Mobile Health Intervention to Support Patients With Active Tuberculosis

Conditions
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Tuberculosis, Adherence, Medication

Intervention / Treatment
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* Behavioral: Mobile phone TB treatment support app plus usual care
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile phone TB treatment support app<br>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<br>* 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.<br>Other: Usual care<br>* 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.<br>|
| Active Comparator: Usual care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability (perceived usefulness and ease of use) | 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. | 6 months | 
| Feasibility of implementation | Semi-structured interview with participants to understand challenges, recommendations for improvement. Observations | 6 months | 
| Initial efficacy - Treatment outcome | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Health Patient-Reported Outcomes Measurement Information System (PROMIS) short form | The Global Health short form (SF) is a recommended outcome measure for self-management, includes 10 items | day 1 and 6 months | 
| Tuberculosis Knowledge Assessment Questionnaire | 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). | day 1 and 6 months | 
| Engagement | Level of engagement using the app will be measured by percentage of notification without a reminder, number of questions, number of reported side effects. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile Health