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Understanding Magnetic Resonance Imaging in Multiple Sclerosis (UMIMS)

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ClinicalTrials.gov Identifier: NCT03872583
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Clinically Isolated Syndrome Other: Understanding MRI in MS (website) Other: Control website Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double-blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, physicians, outcome assessors and investigator will be blinded.
Primary Purpose: Other
Official Title: Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872583


Contacts
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Contact: Christoph Heesen, Prof. +49 7410 ext 53776 heesen@uke.de
Contact: Insa Schiffmann, Dr. +49 152 22815796 i.schiffmann@uke.de

Locations
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Germany
University Medical Centre Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Insa Schiffmann, Dr.       i.schiffmann@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Sanofi
Investigators
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Principal Investigator: Christoph Heesen, Prof. University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis

Publications:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03872583     History of Changes
Other Study ID Numbers: PV5722
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Patient education
Disease-specific knowledge
Shared decision making

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases