O ensaio piloto de adaptação de medidas de resultados específicos para doenças para telessaúde em Miastenia Gravis (ADAPT-teleMG)
O ensaio piloto de adaptação de medidas de resultados específicos para doenças para telessaúde em Miastenia Gravis (ADAPT-teleMG)
The goal of this pilot study is to determine the reliability of myasthenia gravis (MG) specific outcome measures obtained during virtual encounters with patients with myasthenia gravis. The main question it aims to answer is: Are MG-specific outcome measures obtained during virtual encounters reliable?
Participants will complete two virtual study visits in which they will be administered common MG-specific outcome measures and a newly developed outcome measure developed specifically for telemedicine assessments of MG patients.
Visão geral do estudo
Descrição detalhada
The purpose of this study is to better understand the use of modified clinical assessments during telehealth visits for patients with Myasthenia Gravis (MG). The study will consist of 2 virtual telemedicine visits. A screening visit will be conducted to optimize the telemedicine environment, provide training on the telemedicine platform being used in the study, and collect demographic, medical history, and medication information. Participants who meet eligibility requirements will have a telemedicine visit (Visit 1) with a study doctor where assessments adapted for the telemedicine environment will be performed. Participants will also be asked to fill out questionnaires related to MG or their experience with telemedicine either online or with the study investigators. A second visit (Visit 2), conducted within 3 days (+/- 1 day), will replicate the assessments performed in V1. Visit 1 and Visit 2 will be recorded for later review by study team members. The investigators hope to establish the effectiveness of these clinical tools in order to better manage MG in the future in clinical care and research study visits.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20037
- George Washington University
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Approximately 50 adult participants with a confirmed diagnosis of MG will be enrolled with a range of disease activity from approximately 7 MGNet clinical study sites
Descrição
Inclusion Criteria:
- Has the capacity to understand and sign an informed consent form
- Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single-fiber electromyography or positive edrophonium test
- Subject has been previously evaluated in a face-to-face clinical encounter at one of the participating study sites within the prior 3 years
- Primary language is English, or equivalent level of English language fluency
- Required disease severity range from asymptomatic-mild to moderate-severe as previously judged by the Investigator.
Exclusion Criteria:
- Inadequate technology for telehealth visits as assessed by the Investigator (e.g., no internet connection, no laptop/tablet with video capability, etc). Cellular phones are not acceptable. Subjects must use a laptop or tablet.
- Is unable or unwilling to comply with the study procedures, including video recording, or telehealth visit.
- Any significant medical/psychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance
- Known pregnancy
- MGFA severity class IVb or V
- Concurrent participation in an interventional clinical trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Neurological Outpatients
Participants in this group will be recruited from the outpatient clinical population at participating MGNet sites. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study. |
Two video telehealth visits will be conducted and recorded within 3 days of one another (+/- 1 day) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score.
Prazo: 3 days (+/- 1 day)
|
Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score will be estimated between two independent rater assessments performed on Visit 1 (V1) and Visit 2 (V2). The MGC score is a validated, patient-reported 10-item assessment tool for evaluating the symptoms and signs of MG. Patient assessment includes self-report of impact (normal, mild, moderate, or severe) and is additionally weighted for clinical significance. Total score ranges from 0 to 50, with higher scores indicating a greater impact of MG on functional activities. A three point change is considered clinical meaningful. This brief assessment takes approximately 10 minutes to complete. |
3 days (+/- 1 day)
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Intrarater reliability (test-retest reliability) of the MGC-v score.
Prazo: 3 days (+/- 1 day)
|
Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score will be estimated between two independent rater assessments performed on Visit 1 (V1) and Visit 2 (V2). The MGC score is a validated, patient-reported 10-item assessment tool for evaluating the symptoms and signs of MG. Patient assessment includes self-report of impact (normal, mild, moderate, or severe) and is additionally weighted for clinical significance. Total score ranges from 0 to 50, with higher scores indicating a greater impact of MG on functional activities. A three point change is considered clinical meaningful. This brief assessment takes approximately 10 minutes to complete. |
3 days (+/- 1 day)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard Nowak, MD, MS, Yale University
- Investigador principal: Amanda Guidon, MD, MPH, Massachusetts General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças Musculares
- Manifestações Neuromusculares
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Doenças Neuromusculares
- Doenças Neurodegenerativas
- Síndromes Paraneoplásicas do Sistema Nervoso
- Neoplasias do Sistema Nervoso
- Síndromes Paraneoplásicas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Fraqueza muscular
- Miastenia grave
- Doenças autoimunes
- Doenças do Sistema Nervoso
- Doenças do sistema imunológico
- Doenças Autoimunes do Sistema Nervoso
- Doenças da Junção Neuromuscular
- Administração de Serviços de Saúde
- Prestação de cuidados de saúde
- Gerenciamento de atendimento ao paciente
- Telemedicina
Outros números de identificação do estudo
- 2000030599
- 1U54NS115054-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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