Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
研究概览
简要总结
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For MS Participants:
- •Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
- •Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive
- •For All Participants:
- •Weight: 45 to 110 kilograms (kg)
排除标准
- •For MS Participants:
- •Severely ill and unstable participants as per investigator's discretion
- •Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment
- •For All Participants:
- •Pregnant or lactating, or intending to become pregnant during the study
研究组 & 干预措施
A: MS Participants
MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.
干预措施: Smartphone and Smartwatch (Device)
B: Healthy Controls
Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.
干预措施: Smartphone and Smartwatch (Device)
结局指标
主要结局
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
时间窗: Week 24
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks
时间窗: Week 12
Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
时间窗: Week 12
Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
时间窗: Week 24
次要结局
未报告次要终点