Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917184
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2023-06-14
Brief Title:
The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis ADAPT-teleMG
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT-teleMG
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U54NS115054-01 | NIH | None | httpsreporternihgovquickSearch1U54NS115054-01 |