Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

Description

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.

Conditions

Neuromyelitis Optica

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

Condition
Neuromyelitis Optica
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Sacramento

University of California Davis Health, Sacramento, California, United States, 95817

Tampa

University of south Florida, Tampa, Florida, United States, 33612

Evanston

NorthShore University HealthSystem, Evanston, Illinois, United States, 60201

Baltimore

Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center), Baltimore, Maryland, United States, 21287

Boston

Massachussets General Hospital, Boston, Massachusetts, United States, 02114

Washington

Washington University in St. Louis, Washington, Missouri, United States, 63130

Las Vegas

CC Lou Ruvo Center for Brain Health, Las Vegas, Nevada, United States, 89106

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27514

Oklahoma City

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ad scientiam,

Study Record Dates

2026-04