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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT05917184

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH), National Center for Advancing Translational Sciences (NCATS) (NIH)

Enrollment

Locations

16.7

Actual Duration (Months)

10.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis	Other: Telehealth

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 30, 2021

Actual Primary Completion Date :

Jan 20, 2023

Actual Study Completion Date :

Jan 20, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Other: Telehealth

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

Outcome Measures

Primary Outcome Measures

Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score. [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.
Intrarater reliability (test-retest reliability) of the MGC-v score. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06519
2	George Washington University	Washington	District of Columbia	United States	20037
3	University of Chicago	Chicago	Illinois	United States	60637
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Duke University Medical Center	Durham	North Carolina	United States	27710