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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAd scientiam

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NMOSDCopilot smartphone application

Treatment groups

103 Participants
are divided into 1 treatment group

Sponsors and collaborators