The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis

Myasthenia Gravis Clinical Trial

— ADAPT-teleMG  

Official title:

The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis (ADAPT-teleMG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917184
• Other study ID #: 2000030599
• Secondary ID: 1U54NS115054-01
• Status: Completed
• Start date: August 30, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: June 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Other:
• Telehealth
Two video telehealth visits will be conducted and recorded within 3 days of one another (+/- 1 day)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Yale University	New Haven	Connecticut
United States	George Washington University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score.	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)
Primary	Intrarater reliability (test-retest reliability) of the MGC-v score.	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)