Die Pilotstudie zur Anpassung krankheitsspezifischer Ergebnismessungen für Telegesundheit bei Myasthenia gravis (ADAPT-teleMG)
Die Pilotstudie zur Anpassung krankheitsspezifischer Ergebnismessungen für Telegesundheit bei Myasthenia 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06519
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20037
- George Washington University
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637
- University of Chicago
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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) |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score.
Zeitfenster: 3 days (+/- 1 day)
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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.
Zeitfenster: 3 days (+/- 1 day)
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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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Richard Nowak, MD, MS, Yale University
- Hauptermittler: Amanda Guidon, MD, MPH, Massachusetts General Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Neuromuskuläre Manifestationen
- Pathologische Prozesse
- Neubildungen nach Standort
- Neubildungen
- Neuromuskuläre Erkrankungen
- Neurodegenerative Krankheiten
- Paraneoplastische Syndrome, Nervensystem
- Neubildungen des Nervensystems
- Paraneoplastische Syndrome
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Muskelschwäche
- Myasthenia gravis
- Autoimmunerkrankungen
- Erkrankungen des Nervensystems
- Erkrankungen des Immunsystems
- Autoimmunerkrankungen des Nervensystems
- Erkrankungen der neuromuskulären Verbindungen
- Verwaltung des Gesundheitswesens
- Lieferung der Gesundheitsversorgung
- Patientenversorgung Management
- Telemedizin
Andere Studien-ID-Nummern
- 2000030599
- 1U54NS115054-01 (US NIH Stipendium/Vertrag)
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