Mobile Health Intervention for Active Tuberculosis
8 de dezembro de 2020 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
42
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Province Of Buenos Aires
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Vicente López, Province Of Buenos Aires, Argentina, 1602
- Hospital Dr. Antonio A. Cetrángolo
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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).
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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.
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.
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Comparador Ativo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Acceptability (perceived usefulness and ease of use)
Prazo: 6 months
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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.
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6 months
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Feasibility of implementation
Prazo: 6 months
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Semi-structured interview with participants to understand challenges, recommendations for improvement.
Observations
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6 months
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Initial efficacy - Treatment outcome
Prazo: 6 months
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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).
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Global Health Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Prazo: day 1 and 6 months
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The Global Health short form (SF) is a recommended outcome measure for self-management, includes 10 items
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day 1 and 6 months
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Tuberculosis Knowledge Assessment Questionnaire
Prazo: day 1 and 6 months
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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).
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day 1 and 6 months
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Engagement
Prazo: 6 months
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Level of engagement using the app will be measured by percentage of notification without a reminder, number of questions, number of reported side effects.
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6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sarah Iribarren, PhD, RN, University of Washington
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de abril de 2019
Conclusão Primária (Real)
31 de março de 2020
Conclusão do estudo (Real)
31 de julho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2018
Primeira postagem (Real)
1 de junho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de dezembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de dezembro de 2020
Última verificação
1 de dezembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00002080
- K23NR017210 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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