Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ad scientiam
- 入组人数
- 103
- 试验地点
- 42
- 主要终点
- To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
NMOSDCopilot
Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
干预措施: NMOSDCopilot smartphone application (Device)
结局指标
主要结局
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
时间窗: Standard tests results at Baseline versus e-active tests results at D0 + 7 days
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
次要结局
- To assess test-retest reliability of at-home 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(Baseline, month 6, month 12)
- To assess pain(Month 3, month 6, month 12)
- To assess bladder control(Month 3, month 6, month 12)
- To assess bowel control(Month 3, month 6, month 12)
- To assess at-home compliance and adherence to the patient application(Through study completion, 21 months)
- To assess reproducibility between in-clinic and at-home e-active tests(Baseline, day 7, month 6 - 7 days, month 6)
- To assess quality of life(Baseline, month 6, month 12)
- To assess fatigue(Month 3, month 6, month 12)
- To assess disability(Baseline, month 6, month 12)
- To assess satisfaction and user experience with the smartphone application and the web dashboard(Through study completion, 21 months)
- To assess the adverse events related to of the mobile application use.(through study completion, 21 months)
- To assess depression(Month 3, month 6, month 12)
- To compare results obtained with at home MVT and in-clinic OCT-scan(Through study completion, 21 months)