Идёт набор NCT05564936

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

Без фазы С лечением Myasthenia Gravis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ME&MG mobile application.
Кому может быть актуально: Состояния в реестре: Myasthenia Gravis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study

Обзор

ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.

Подробное описание

Myasthenia gravis (MG) is an autoimmune neuromuscular disease characterised by fatigable muscle weakness due to autoantibodies targeting components of the neuromuscular junction.

Deficits are measured using validated clinical scales such as the Quantitative Myasthenia Gravis score (QMG) QMG, Myasthenia Gravis Composite Score (MCS), Myasthenia Gravis Activities of Daily Living score (MG-ADL), etc., Unfortunately, this type of assessment might require expensive material, time, and personnel training, which make MG assessment difficult for clinicians in routine care.

Research on the matter has highlighted the importance of Patient-Reported Outcomes (PROs), composite measures of disease severity and quality-of-life measurements. This has led to the development of a number of tools for the self-assessment of PROs with validated questionnaires. However, there is no tool that overcomes the constraints of standard tests such as the QMG while allowing for the collection of objective data and PROs between visits.

ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.

The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.

Вмешательства

Устройство ME&MG mobile application
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.

Первичные конечные точки

To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions [Срок оценки: baseline]

Вторичные конечные точки (12)

To compare results between in-clinic digital tests and in-clinic standard tests, test to test [Срок оценки: baseline]
To assess reproducibility between in-clinic digital tests and at-home digital tests [Срок оценки: baseline, day 1, day 89, day 90]
To assess test-retest reliability of at-home digital tests [Срок оценки: Day1, Day 2, Day 3, Day 87, Day 88, Day 89]
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score [Срок оценки: baseline, day 1]
To assess adverse events related to the use of the mobile application [Срок оценки: through study completion, an average of 1 year]
To assess satisfaction and user experience with the smartphone application [Срок оценки: through study completion, an average of 1 year]
To assess correlation of the at-home ME&MG composite score with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score [Срок оценки: baseline, day 90, day 365]
to assess daily activites [Срок оценки: 12 months]
to assess depression [Срок оценки: 12 months]
to assess pain [Срок оценки: 12 months]
to assess insomnia [Срок оценки: 12 months]
To assess at-home compliance to the ME&MG smartphone application [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

Aged over 18 Years
Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
With positive serologic testing for anti-AChR autoantibody at screening
Have read the information sheet and signed the informed consent form
Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
Able to use a smartphone
Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms

Критерии исключения

Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
Pregnant and nursing women
Person under guardianship or curatorship
Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
Participant included in another ME\&MG clinical study
Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да