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

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.

Interventions

• 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

Primary outcome measures

• To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test [Time frame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days]

Secondary outcome measures (12)

• To assess reproducibility between in-clinic and at-home e-active tests [Time frame: Baseline, day 7, month 6 - 7 days, month 6]
• To assess test-retest reliability of at-home 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 [Time frame: Baseline, month 6, month 12]
• To assess the adverse events related to of the mobile application use. [Time frame: through study completion, 21 months]
• To assess pain [Time frame: Month 3, month 6, month 12]
• To assess fatigue [Time frame: Month 3, month 6, month 12]
• To assess bladder control [Time frame: Month 3, month 6, month 12]
• To assess bowel control [Time frame: Month 3, month 6, month 12]
• To assess depression [Time frame: Month 3, month 6, month 12]
• To assess quality of life [Time frame: Baseline, month 6, month 12]
• To assess disability [Time frame: Baseline, month 6, month 12]
• To assess satisfaction and user experience with the smartphone application and the web dashboard [Time frame: Through study completion, 21 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 10 centers

• University of Southern California — Los Angeles
• University of California Davis Health — Sacramento
• University of south Florida — Tampa
• NorthShore University HealthSystem — Evanston
• Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) — Baltimore
• Massachussets General Hospital — Boston
• Washington University in St. Louis — Washington
• CC Lou Ruvo Center for Brain Health — Las Vegas
• … and 2 more centers

France · 8 centers

• Hôpital Roger Salengro — Lille
• CHU Marseille - La Timone — Marseille
• CHU de Montpellier — Montpellier
• Hopital Pasteur 2 — Nice
• Hopital La Pitié Salpétrière — Paris
• CHU Rouen — Rouen
• Hopital de Hautepierre — Strasbourg
• CHU Toulouse - Hôpital Purpan — Toulouse

Germany · 4 centers

• Universitätsklinikum Carl Gustav Carus — Dresden
• Universitätsklinik Essen — Essen
• University Munich — Munich
• Hopital Rechts der Isar der Technischen Universitat Munchen — Munich

Identifiers

NCT: NCT05566769 · OPTIS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗