Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial

CompletedNot a drug-phase studyRelapsing MSNCT03872583

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Understanding MRI in MS (website)

Compared with

  • Control website

What it measured

Main measures

  • Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)

    2 weeks

    MRI lesions

Other measures (5)

  • Emotions and attitude towards magnetic resonance imaging (MRI-EMA)

    Baseline, 2 weeks

    MRI lesions
  • Control preference scale (CPS)

    Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)

  • Threat by MS

    baseline, 2 weeks

    Mood and sleep
  • Hospital Anxiety and Depression Scale (HADS)

    Baseline, 2 weeks

    Mood and sleep
  • Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)

    after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Mar 2019

    2. Main results due

      Dec 2022

    3. Finished

      Dec 2022

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