Understanding Magnetic Resonance Imaging in Multiple Sclerosis (UMIMS)

December 27, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Centre Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Understanding MRI in MS (website)
Participants will receive access to a newly developed, innovative, interactive and evidence-based education tool about magnetic resonance imaging in multiple sclerosis.
Other: Understanding MRI in MS (website)
Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.
Active Comparator: Control website
Participants will receive access to a specifically designed control website containing the information about magnetic resonance imaging in multiple sclerosis, that is freely available on the websites of major European multiple sclerosis self help organization (Australia, Belgium, Canada, France, Germany, Great Britain, Netherland, USA).
Other: Control website
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 weeks
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)
Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)
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)
baseline, 2 weeks
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)
Baseline, 2 weeks
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)
after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Sanofi

Investigators

  • Principal Investigator: Christoph Heesen, Prof., University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV5722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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