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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuromyelitis Optica

Intervention / Treatment
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* Device: NMOSDCopilot smartphone application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: One group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMOSDCopilot<br>Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months | Device: NMOSDCopilot smartphone application<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| To assess pain | Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome | Month 3, month 6, month 12 | 
| To assess fatigue | Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome | Month 3, month 6, month 12 | 
| To assess bladder control | Bladder Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 | 
| To assess bowel control | Bowel Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 | 
| To assess depression | Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome | Month 3, month 6, month 12 | 
| To assess quality of life | p-value of multivariate analysis for non-parametric data | Baseline, month 6, month 12 | 
| To assess disability | Expanded Disability Status Scale (0-10), higher score meaning a worse outcome | Baseline, month 6, month 12 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder