Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)
研究概览
简要总结
Magnetic resonance imaging (MRI) results play a major role in the lives of people with multiple sclerosis (pwMS). Even though MRI is used for diagnosis, prognosis and therapy control, pwMS' knowledge concerning this complex matter is scarce. Without adequate disease-specific knowledge, pwMS cannot truly make an informed choice when considering their MRI results (e.g. necessity of future MRI scans or therapy change).
The investigators have developed an innovative, evidence-based and interactive online education tool called "Understanding MRI in MS", which incorporates all relevant information about MRI in MS and its implications in disease management.
In this randomized, controlled and double-blind trial the tool's effect on MRI-specific knowledge, self-perceived competence and involvement in medical decision, that are based on MRI results will be assessed.
详细描述
For the randomized controlled trial (RCT), n=120 consecutive patients of 4 centers, for whom a brain (or brain and spine) MRI scan is planned within the next 6 months, will be invited to participate in the trial. Eligible patients will be asked to participate, and, if willing, will receive information about the study by the recruiting physician and written consent will be obtained. Participants will then answer a baseline questionnaire including demographic data, numeracy, attitude and emotions towards MRI (MRI-emotions and attitude questionnaire, MRI-EMA, newly developed) and MRI-specific knowledge (MRI-risk knowledge questionnaire 2.0, MRI-RIKNO 2.0, newly developed).
Patients will then be randomized into two groups: The intervention group of n=60 participants gets access to the web-based educational tool, the control group of n=60 to a sham intervention with standard information on MRI.
Participants will be asked to provide an e-mail address via which the login for the educational tool will be delivered. After two weeks participants will be asked to fill out the following tools:
Primary endpoint
- MRI-risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0) (newly developed)
- MRI-emotions and attitude questionnaire (MRI-EMA) (newly developed)
- Threat by MS
- Autonomy preferences (Control Preference Scale)
- Subjective knowledge (VAS scale) (22)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, physicians, outcome assessors and investigator will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years 65 years
- •MRI within 6 weeks to 6 months
- •internet access AND
- •diagnosis of relapsing-remitting MS (RRMS) according to the McDonald criteria (Thompson et al., 2018), <10 years disease duration + active disease course (i.e. therapy change or new T2 lesion within the previous year) OR
- •clinically isolated syndrome (CIS) (with at least one MS-typical T2 lesion)
排除标准
- •diagnosis of secondary-progressive MS
- •diagnosis of primary-progressive MS
- •diagnosis or suspected central nervous system disease other than MS
- •severe cognitive deficit
- •major psychiatric illness
- •patients who are related to medical personnel
结局指标
主要结局
Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)
时间窗: 2 weeks
15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)
次要结局
- Emotions and attitude towards magnetic resonance imaging (MRI-EMA)(Baseline, 2 weeks)
- Threat by MS(baseline, 2 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 2 weeks)
- Control preference scale (CPS)(Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline))
- Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)(after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline))