Neuromyelitis Optica Clinical Trial
— OPTISOfficial title:
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
NCT number | NCT05566769 |
Other study ID # | OPTIS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 3, 2023 |
Est. completion date | July 1, 2025 |
Verified date | March 2024 |
Source | Ad scientiam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 103 |
Est. completion date | July 1, 2025 |
Est. primary completion date | November 3, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro | Lille | |
France | CHU de Montpellier | Montpellier | |
France | Hopital Pasteur 2 | Nice | |
France | Hopital La Pitié Salpétrière | Paris | |
France | CHU Rouen | Rouen | |
France | Hopital de Hautepierre | Strasbourg | |
United States | Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) | Baltimore | Maryland |
United States | Massachussets General Hospital | Boston | Massachusetts |
United States | NorthShore University HealthSystem | Evanston | Illinois |
United States | CC Lou Ruvo Center for Brain Health | Las Vegas | Nevada |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
United States | University of south Florida | Tampa | Florida |
United States | Washington University in St. Louis | Washington | Missouri |
Lead Sponsor | Collaborator |
---|---|
Ad scientiam |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | To assess pain | Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome | Month 3, month 6, month 12 | |
Secondary | To assess fatigue | Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome | Month 3, month 6, month 12 | |
Secondary | To assess bladder control | Bladder Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 | |
Secondary | To assess bowel control | Bowel Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 | |
Secondary | To assess depression | Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome | Month 3, month 6, month 12 | |
Secondary | To assess quality of life | p-value of multivariate analysis for non-parametric data | Baseline, month 6, month 12 | |
Secondary | To assess disability | Expanded Disability Status Scale (0-10), higher score meaning a worse outcome | Baseline, month 6, month 12 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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