Clinical trial NCT03872583: Understanding Magnetic Resonance Imaging in Multiple Sclerosis
Official title: Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Clinically Isolated Syndrome
Keywords: Patient education
Disease-specific knowledge
Shared decision making
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2019-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, double-blind trial
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)
timeFrame: 2 weeks
Secondary outcomes:
measure: Emotions and attitude towards magnetic resonance imaging (MRI-EMA)
timeFrame: Baseline, 2 weeks
measure: Control preference scale (CPS)
timeFrame: Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)
measure: Threat by MS
timeFrame: baseline, 2 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 2 weeks
measure: Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)
timeFrame: after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis
name: Christoph Heesen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brand J, Kopke S, Kasper J, Rahn A, Backhus I, Poettgen J, Stellmann JP, Siemonsen S, Heesen C. Magnetic resonance imaging in multiple sclerosis--patients' experiences, information interests and responses to an education programme. PLoS One. 2014 Nov 21;9(11):e113252. doi: 10.1371/journal.pone.0113252. eCollection 2014.
citation: Gaissmaier W, Giese H, Galesic M, Garcia-Retamero R, Kasper J, Kleiter I, Meuth SG, Kopke S, Heesen C. Numeracy of multiple sclerosis patients: A comparison of patients from the PERCEPT study to a German probabilistic sample. Patient Educ Couns. 2018 Jan;101(1):74-78. doi: 10.1016/j.pec.2017.07.018. Epub 2017 Jul 17.
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citation: Kasper J, Hoffmann F, Heesen C, Kopke S, Geiger F. MAPPIN'SDM--the multifocal approach to sharing in shared decision making. PLoS One. 2012;7(4):e34849. doi: 10.1371/journal.pone.0034849. Epub 2012 Apr 13.
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