Understanding Magnetic Resonance Imaging in Multiple Sclerosis
Understanding Magnetic Resonance Imaging in Multiple Sclerosis
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.
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)

 Within the course of 2 weeks to 6 months the scheduled MRI will take place, followed by a
 patient-physician encounter, in which the MRI results are discussed. Directly after this
 encounter patients and physicians will be asked to answer MAPPIN'SDM questionnaires to assess
 perceived shared decision making behaviour and realization of autonomy preferences (Control
 reference scale). All patients will also be asked questions concerning any decisions taken
 based on the MRI, either a start/change of treatment or agreement on a new MRI in a defined
 time-frame. N=5 patients of each arm in the study center in Hamburg will be randomly selected
 and the communication of results during this consultation will be audiotaped and evaluated
 using the MAPPIN'SDM observer rating approach.

 In a telephone follow-up after 6 months, implementation of the decisions will be checked.
Inclusion Criteria:

 -  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)

 Exclusion Criteria:

 -  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