Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Ad scientiam
- Study ID
- NCT05566769
- Status
- Recruiting
Conditions
- Neuromyelitis Optica
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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
Study Details
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.
Key Dates
- Start date
- Nov 3, 2023
- Status verified
- Apr 2025
- Primary completion
- Sep 30, 2025
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 103 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: NMOSDCopilotPerformance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
Primary Outcome Measure
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test [ Time Frame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days ]
Central Contacts
- Dr Levy617-726-7565
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | Dr Amezcua (PRINCIPAL_INVESTIGATOR) |
| University of California Davis Health | Sacramento | California | 95817 | Dr Apperson (PRINCIPAL_INVESTIGATOR) |
| University of south Florida | Tampa | Florida | 33612 | Dr Ciotti (PRINCIPAL_INVESTIGATOR) |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | Dr Hentati (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) | Baltimore | Maryland | 21287 | Dr Sotirchos (PRINCIPAL_INVESTIGATOR) |
| Massachussets General Hospital | Boston | Massachusetts | 02114 | Dr Levy (PRINCIPAL_INVESTIGATOR) |
| Washington University in St. Louis | Washington | Missouri | 63130 | Dr Naismith (PRINCIPAL_INVESTIGATOR) |
| CC Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | Dr Le Hua (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Dr Dujmovic (PRINCIPAL_INVESTIGATOR) |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 |
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