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NCT Number: NCT03872583

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Understanding MRI in MS (website)

Other

Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.

Control website

Other

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.

Primary outcomes

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

    Time frame: 2 weeks

    15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)

Secondary outcomes

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

    Time frame: Baseline, 2 weeks

    Validated 10-item questionnaire on emotions and attitude towards magnetic resonance imaging, sub-scales (min. value: 1, max. value: 4; higher values indicate greater expression of the feature): 1) Fear of MRI scan, 2) Fear of MRI results, 3) Feeling of control, 4) Feeling of competence

  2. Control preference scale (CPS)

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

    Scale to assess autonomy preferences during medical decisions (5 categories between complete autonomy and paternalistic decision making as the extremes)

  3. Threat by MS

    Time frame: baseline, 2 weeks

    Visual analogue scale to assess anxiety associated with disease progression (min. 0, max. 100; higher values indicate higher subjective threat)

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, 2 weeks

    Questionnaire to assess anxiety and depression (min. 0, max. 42 points (21 points for each subscale, subscales are added); higher values indicate more severe depression/anxiety)

  5. Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)

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

    Tool to assess the amount of shared decision making during a patient-physician encounter (min. value 0, max. value 45; higher values indicated higher level of shared decision making)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: UMIMS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2019
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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