Clinical trial NCT05566769: Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Official title: Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromyelitis Optica
Keywords: NMO
NMOSD
Neuromyelitis optica
Neuromyelitis optica spectrum disorder
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
timeFrame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Secondary outcomes:
measure: To assess reproducibility between in-clinic and at-home e-active tests
timeFrame: Baseline, day 7, month 6 - 7 days, month 6
measure: To assess test-retest reliability of at-home e-active tests
timeFrame: Month 1, month 2, month 3, month 4, month 5
measure: To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
timeFrame: Baseline, month 6, month 12
measure: To assess the adverse events related to of the mobile application use.
timeFrame: through study completion, 21 months
measure: To assess pain
timeFrame: Month 3, month 6, month 12
measure: To assess fatigue
timeFrame: Month 3, month 6, month 12
measure: To assess bladder control
timeFrame: Month 3, month 6, month 12
measure: To assess bowel control
timeFrame: Month 3, month 6, month 12
measure: To assess depression
timeFrame: Month 3, month 6, month 12
measure: To assess quality of life
timeFrame: Baseline, month 6, month 12
measure: To assess disability
timeFrame: Baseline, month 6, month 12
measure: To assess satisfaction and user experience with the smartphone application and the web dashboard
timeFrame: Through study completion, 21 months
measure: To assess at-home compliance and adherence to the patient application
timeFrame: Through study completion, 21 months
measure: To compare results obtained with at home MVT and in-clinic OCT-scan
timeFrame: Through study completion, 21 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
city: Tampa
country: United States
facility: University of south Florida
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
state: Maryland
city: Boston
country: United States
facility: Massachussets General Hospital
state: Massachusetts
city: Washington
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: CC Lou Ruvo Center for Brain Health
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Marseille
country: France
facility: CHU Marseille - La Timone
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: Hopital Pasteur 2
city: Paris
country: France
facility: Hopital La Pitié Salpétrière
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpan
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Universitätsklinik Essen
city: Munich
country: Germany
facility: University Munich
city: Munich
country: Germany
facility: Hopital Rechts der Isar der Technischen Universitat Munchen
Study officials:
References: