The Multiple Sclerosis Self Monitoring Study: An Intervention Study on the Effect of Digital Self-monitoring-based Management of Relapsing and Remitting Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C)
研究概览
简要总结
This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Able to comply with the study protocol, as judged by the investigator.
- •A minimum age of 18 years.
- •Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
- •Have a length of disease duration of ≥12 months, from date of MS diagnosis.
- •Have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or T1 contrast-enhancing lesions) within the past 12 months.
- •Willing and able to install and use MS sherpa® on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system.
- •Willing to stay for treatment with the same hospital during the year of study.
- •Willing to follow the rules of conduct as described in Appendix A during the year of study.
排除标准
- •EDSS of > 6.5 at baseline screening.
- •Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
- •Concomitant use of health monitoring apps or devices for MS during the study.
- •Concomitant participation in another intervention trial in MS.
结局指标
主要结局
the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C)
时间窗: One year
the MS Self-Efficacy scale is an 18-item scale assessing self-rated certainty regarding specific behaviours related to functional independence and psychological management of MS. Items are rated on a scale from 10 (very uncertain) to 100 (very certain). The MSSE consist of two subscales by summing the respective items: SE Function, and SE Control.
次要结局
- Decision making process - patient(One year)
- Decision making process - caregiver(One year)
研究者
Joep Killestein
Prof.
Amsterdam UMC, location VUmc