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Mobile Health Intervention for Active Tuberculosis

8 de diciembre de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Conductual: 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.
Otro: 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.
Comparador activo: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acceptability (perceived usefulness and ease of use)
Periodo de tiempo: 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
Periodo de tiempo: 6 months
Semi-structured interview with participants to understand challenges, recommendations for improvement. Observations
6 months
Initial efficacy - Treatment outcome
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Global Health Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Washington

Colaboradores

National Institute of Nursing Research (NINR)

Investigadores

  • Investigador principal: Sarah Iribarren, PhD, RN, University of Washington

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de abril de 2019

Finalización primaria (Actual)

31 de marzo de 2020

Finalización del estudio (Actual)

31 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2018

Publicado por primera vez (Actual)

1 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

8 de diciembre de 2020

Última verificación

1 de diciembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00002080
  • K23NR017210 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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