Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
OPTIS
1 other identifier
interventional
103
3 countries
22
Brief Summary
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedStudy Start
First participant enrolled
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedApril 10, 2025
April 1, 2025
1.8 years
September 7, 2022
April 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline
Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Secondary Outcomes (14)
To assess reproducibility between in-clinic and at-home e-active tests
Baseline, day 7, month 6 - 7 days, month 6
To assess test-retest reliability of at-home e-active tests
Month 1, month 2, month 3, month 4, month 5
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Baseline, month 6, month 12
To assess the adverse events related to of the mobile application use.
through study completion, 21 months
To assess pain
Month 3, month 6, month 12
- +9 more secondary outcomes
Study Arms (1)
NMOSDCopilot
EXPERIMENTALPerformance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
Interventions
NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression
Eligibility Criteria
You may qualify if:
- Aged over 18 years old
- NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
- With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
- EDSS =\< 7
- With no evidence of relapse in the past 3 months before enrollment
- Who have read the information sheet and signed the informed consent form
- Able to use a smartphone
- Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
- Able to read language in which the mobile application is available and able to understand pictograms
You may not qualify if:
- Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
- Pregnant and nursing women
- Person under guardianship or curatorship
- Bedridden patients or patients with a daily activity of less than 2 hours per day
- Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
- Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ad scientiamlead
Study Sites (22)
University of Southern California
Los Angeles, California, 90033, United States
University of California Davis Health
Sacramento, California, 95817, United States
University of south Florida
Tampa, Florida, 33612, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Baltimore, Maryland, 21287, United States
Massachussets General Hospital
Boston, Massachusetts, 02114, United States
Washington University in St. Louis
Washington, Missouri, 63130, United States
CC Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Hôpital Roger Salengro
Lille, 59037, France
CHU Marseille - La Timone
Marseille, 13385, France
CHU de Montpellier
Montpellier, 34295, France
Hopital Pasteur 2
Nice, 06000, France
Hopital La Pitié Salpétrière
Paris, France
CHU Rouen
Rouen, 76038, France
Hopital de Hautepierre
Strasbourg, 67000, France
CHU Toulouse - Hôpital Purpan
Toulouse, 31059, France
Universitätsklinikum Carl Gustav Carus
Dresden, 01397, Germany
Universitätsklinik Essen
Essen, 45147, Germany
University Munich
Munich, 80336, Germany
Hopital Rechts der Isar der Technischen Universitat Munchen
Munich, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
October 4, 2022
Study Start
November 3, 2023
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share