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Mobile Health Intervention for Active Tuberculosis

8 december 2020 uppdaterad av: Sarah Iribarren, University of Washington

Interactive Mobile Health Intervention to Support Patients With Active Tuberculosis

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

42

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
    • Province Of Buenos Aires
      • Vicente López, Province Of Buenos Aires, Argentina, 1602
        • Hospital Dr. Antonio A. Cetrángolo

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Beteende: 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.
Övrig: 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.
Aktiv komparator: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptability (perceived usefulness and ease of use)
Tidsram: 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.
6 months
Feasibility of implementation
Tidsram: 6 months
Semi-structured interview with participants to understand challenges, recommendations for improvement. Observations
6 months
Initial efficacy - Treatment outcome
Tidsram: 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).
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Global Health Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Tidsram: day 1 and 6 months
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
Tidsram: 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).
day 1 and 6 months
Engagement
Tidsram: 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.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Samarbetspartners

National Institute of Nursing Research (NINR)

Utredare

  • Huvudutredare: Sarah Iribarren, PhD, RN, University of Washington

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 april 2019

Primärt slutförande (Faktisk)

31 mars 2020

Avslutad studie (Faktisk)

31 juli 2020

Studieregistreringsdatum

Först inskickad

21 maj 2018

Först inskickad som uppfyllde QC-kriterierna

21 maj 2018

Första postat (Faktisk)

1 juni 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 december 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 december 2020

Senast verifierad

1 december 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00002080
  • K23NR017210 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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