중증 근무력증의 원격 의료를 위한 적응 질병 특정 결과 측정 파일럿 시험 (ADAPT-teleMG)
중증 근무력증(ADAPT-teleMG)의 원격 의료를 위한 적응 질병 특정 결과 측정 파일럿 시험
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Connecticut
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New Haven, Connecticut, 미국, 06519
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20037
- George Washington University
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interrater reliability of the virtual Myasthenia Gravis Composite (MGC-v) score.
기간: 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. |
3 days (+/- 1 day)
|
|
Intrarater reliability (test-retest reliability) of the MGC-v score.
기간: 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. |
3 days (+/- 1 day)
|
공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Richard Nowak, MD, MS, Yale University
- 수석 연구원: Amanda Guidon, MD, MPH, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000030599
- 1U54NS115054-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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