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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMOSDCopilot | Experimental | Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMOSDCopilot smartphone application | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Levy | Contact | 617-726-7565 | mlevy11@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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One group
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| 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 |
| University of California Davis Health | Recruiting | Sacramento | California | 95817 | United States |
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| University of south Florida | Recruiting | Tampa | Florida | 33612 | United States |
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| NorthShore University HealthSystem | Recruiting | Evanston | Illinois | 60201 | United States |
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| Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachussets General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Washington University in St. Louis | Recruiting | Washington | Missouri | 63130 | United States |
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| CC Lou Ruvo Center for Brain Health | Recruiting | Las Vegas | Nevada | 89106 | United States |
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| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Oklahoma Medical Research Foundation | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Hôpital Roger Salengro | Recruiting | Lille | 59037 | France |
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| CHU Marseille - La Timone | Recruiting | Marseille | 13385 | France |
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| CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
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| Hopital Pasteur 2 | Recruiting | Nice | 06000 | France |
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| Hopital La Pitié Salpétrière | Recruiting | Paris | France |
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| CHU Rouen | Active, not recruiting | Rouen | 76038 | France |
| Hopital de Hautepierre | Completed | Strasbourg | 67000 | France |
| CHU Toulouse - Hôpital Purpan | Recruiting | Toulouse | 31059 | France |
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| Universitätsklinikum Carl Gustav Carus | Recruiting | Dresden | 01397 | Germany |
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| Universitätsklinik Essen | Recruiting | Essen | 45147 | Germany |
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| University Munich | Recruiting | Munich | 80336 | Germany |
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| Hopital Rechts der Isar der Technischen Universitat Munchen | Not yet recruiting | Munich | Germany |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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