Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
ConditionNeuromyelitis Optica
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
NMOSDCopilot smartphone application
DeviceNMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression
Treatment groups
103 Participants
are divided into 1 treatment groupGroup A: NMOSDCopilotExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 62
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 53
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 124
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 monthsSponsors and contacts
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Source ClinicalTrials.gov