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

Neuromyelitis Optica Clinical Trial

— OPTIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566769
• Other study ID #: OPTIS
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: Ad scientiam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: July 1, 2025
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 60 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.

Related Conditions & MeSH terms

• Neuromyelitis Optica

Intervention

Device:
• NMOSDCopilot smartphone application
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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro	Lille
France	CHU de Montpellier	Montpellier
France	Hopital Pasteur 2	Nice
France	Hopital La Pitié Salpétrière	Paris
France	CHU Rouen	Rouen
France	Hopital de Hautepierre	Strasbourg
United States	Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)	Baltimore	Maryland
United States	Massachussets General Hospital	Boston	Massachusetts
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	CC Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of south Florida	Tampa	Florida
United States	Washington University in St. Louis	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ad scientiam

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, day 7, month 6 - 7 days, month 6
Secondary	To assess test-retest reliability of at-home e-active tests	Intraclass correlation coefficient of e-active tests	Month 1, month 2, month 3, month 4, month 5
Secondary	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	Baseline, month 6, month 12
Secondary	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.	through study completion, 21 months
Secondary	To assess pain	Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome	Month 3, month 6, month 12
Secondary	To assess fatigue	Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome	Month 3, month 6, month 12
Secondary	To assess bladder control	Bladder Control Scale (0-22) higher score meaning a worse outcome	Month 3, month 6, month 12
Secondary	To assess bowel control	Bowel Control Scale (0-22) higher score meaning a worse outcome	Month 3, month 6, month 12
Secondary	To assess depression	Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome	Month 3, month 6, month 12
Secondary	To assess quality of life	p-value of multivariate analysis for non-parametric data	Baseline, month 6, month 12
Secondary	To assess disability	Expanded Disability Status Scale (0-10), higher score meaning a worse outcome	Baseline, month 6, month 12
Secondary	To assess satisfaction and user experience with the smartphone application and the web dashboard	Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)	Through study completion, 21 months
Secondary	To assess at-home compliance and adherence to the patient application	Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).	Through study completion, 21 months
Secondary	To compare results obtained with at home MVT and in-clinic OCT-scan	The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF & GCIP layer thickness	Through study completion, 21 months