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

Ad scientiam103 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

103

Conditions

Neuromyelitis Optica

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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 Exclusion Criteria: * 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.

Locations (22)

University of Southern California

Los Angeles, California, United States

RECRUITING

University of California Davis Health

Sacramento, California, United States

RECRUITING

University of south Florida

Tampa, Florida, United States

RECRUITING

NorthShore University HealthSystem

Evanston, Illinois, United States

RECRUITING

Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)

Baltimore, Maryland, United States

RECRUITING

Massachussets General Hospital

Boston, Massachusetts, United States

RECRUITING

Washington University in St. Louis

Washington, Missouri, United States

RECRUITING

CC Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

RECRUITING

...and 12 more locations

Outcomes

Primary Outcomes

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

Time frame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days

Secondary Outcomes

To assess reproducibility between in-clinic and at-home e-active tests

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 and between and month 6 and month 6- 7days

Time frame: Baseline, day 7, month 6 - 7 days, month 6

To assess test-retest reliability of at-home e-active tests

Intraclass correlation coefficient of e-active tests

Time frame: 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

Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests

Time frame: Baseline, month 6, month 12

To assess the adverse events related to of the mobile application use.

descriptive analysis of adverse events (AEs) related to the use of the application.

Time frame: through study completion, 21 months

To assess pain

Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome