A Pilot Validation Study Comparing "DAM" a Smartphone Application With the Composite MSFC Score Intra-individually Among Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ad scientiam
- 入组人数
- 30
- 主要终点
- correlation between the MSFC score and the DAM score
研究概览
简要总结
Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation is not always optimal as it can prove to be very time consuming. Moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status.
A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was developed in order to replicate each of MSFC tests available in order to assess MS progression in the patient environment.
详细描述
Patients are selected during a consultation at the Neurology department of the Pitié-Salpêtrière Hospital (France). Each patient is given access to DAM on their own or a provided iPhone. During the enrolment visit, patients have to complete a MSFC and DAM evaluation (V0). Through a push-notification on their phone, patients are reminded to perform two DAM evaluations at home at days 30 (V1) and 60 (V2). At day 90 (V3), they have to come back to hospital for a second MSFC and DAM evaluation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with an established diagnosis of Multiple sclerosis according to the MacDonald criterias whatever the progression stage, that are monitored by Dr. Maillart as part of her consultation at the Neurology department of the Pitié-Salpêtrière Hospital.
- •Patients with an iPhone (at iOS 8 or higher).
- •Patients age ≥18 years.
- •Patients with an initial score of EDSS between 0 to 6.5
- •No attack since at least 1 month
- •Last Solumedrol injection at least 1 month ago
排除标准
- •Patients who are not capable of using a smartphone application.
- •Patients who do not have the capacity to give their consent.
- •Patients who do not speak French
- •Patients who are bedridden or with a daily activity of less than 2 hours per day
- •Patients with acute asthenia
- •Patients experiencing an attack once enrolled in the study (will be considered as dropouts)
结局指标
主要结局
correlation between the MSFC score and the DAM score
时间窗: At Day 0
次要结局
- correlation between the the MSFC and the DAM score(At Day 90)
- correlation between the DAM score(At Day 60 and Day 90)