RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-03
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05566769

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged over 18 years old
  2. * NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
  3. * With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
  4. * EDSS =\< 7
  5. * With no evidence of relapse in the past 3 months before enrollment
  6. * Who have read the information sheet and signed the informed consent form
  7. * Able to use a smartphone
  8. * Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
  9. * Able to read language in which the mobile application is available and able to understand pictograms
  1. * 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
  2. * Pregnant and nursing women
  3. * Person under guardianship or curatorship
  4. * Bedridden patients or patients with a daily activity of less than 2 hours per day
  5. * Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  6. * 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.

Contacts and Locations

Study Contact

Dr Levy
CONTACT
617-726-7565
mlevy11@mgh.harvard.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ad scientiam

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03
Study Completion Date2026-04

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • NMO
  • NMOSD
  • Neuromyelitis optica
  • Neuromyelitis optica spectrum disorder

Additional Relevant MeSH Terms

  • Neuromyelitis Optica