NCT06922942进行中（未招募）不适用
MS-FLOWER: MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ad scientiam
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis.
研究概览
简要总结
This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both MS patients and clinicians, facilitating broader implementation. Specifically, the study will assess:
- The overall integration of MSCopilot into routine clinical practice,
- Patients' ability to use MSCopilot at home without supervision,
- The need for patient support when using MSCopilot at home,
- User behavior based on usage analytics data from the MSCopilot mobile app and dashboard,
- Patient adherence to MSCopilot use in routine clinical practice,
- The adequacy of the onboarding/training process for HCPs,
- The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding,
- The variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores
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
- •For patients
- •18 years and older
- •With a confirmed and documented MS diagnosis, per the 2010 Revised
- •McDonald criteria
- •With an EDSS score ranging from 0 to 6.5
- •Able to monitor their disease from home (i.e. not hospitalized or under medical assistance).
- •Having a personal smartphone with a mobile operating system above 16 for IOS (iPhone) and 8 for Android and having access to a good internet connection.
- •Able to read language in which the mobile application is available and able to understand pictograms Having read the information sheet and signed the informed consent form
- •Licensed neurologists trained in the management of Multiple Sclerosis patients and allowed to conduct clinical studies within their departments
- •If applicable: nurses or medical assistants specifically trained in the management of Multiple Sclerosis and allowed to participate in clinical studies within their departments
- •Ability to use a computer
排除标准
- •(for patients):
- •Pregnant and nursing women
- •Person under guardianship or curatorship
- •Inability to use a smartphone application
- •Patient who previously participated in a study using MSCopilot
- •Early termination criteria (for patients):
- •exclusion criteria,
- •loss of follow-up,
- •investigator's decision
结局指标
主要结局
To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis.
时间窗: For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)
Descriptive analysis and acceptance criteria of a minimum score of \>2/4 on neurologists' questionnaires regarding the ease of integrating the MSCopilot dashboard into clinical workflows Descriptive analysis and acceptance criteria of a minimum score of \>2/4 on patients' questionnaires regarding the ease of use of MSCopilot at home
次要结局
- To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.(Day 1 to Day 180 (+/-30 days))
- To assess patients' ability to use MSCopilot at home without supervision.(Day 90 (+/-30 days))
- To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.(At Day 180 ± 30days)
- To assess the need for patient support when using MSCopilot at home(Day 180 (+/-30 days))
- To assess patient adherence to MSCopilot use in routine clinical practice.(Day 1 to Day 180 (+/-30 days))
- To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.(Day 1 to Day 180 (+/-30 days))
- To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.(After patient inclusion visit (90 days))
- To assess the adequacy of the onboarding/training process for HCPs, including neurologists, nurses, and medical assistants, focusing on clarity, satisfaction, and confidence in using MSCopilot(After onboarding/training session (Day 0))
研究者
研究点 (8)
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