Understanding Magnetic Resonance Imaging in Multiple Sclerosis
Condition: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Understanding MRI in MS (website); Control website
Intervention type(s): Other; Other
Intervention description(s): Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.; Access to a specifically designed control website containing information on MRI in MS freely available on the websites of major European MS self-help organizations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, double-blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Patient education; Disease-specific knowledge; Shared decision making