Understanding Magnetic Resonance Imaging in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
• Interventions: Other: Understanding MRI in MS (website); Other: Control website

• Registration Number: NCT03872583
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-13
• Study Start: 2019-03-15
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Understanding MRI in MS (website)	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.
Control website	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).

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)	2 weeks	15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)

Secondary Outcome Measures

Name	Time	Method
Emotions and attitude towards magnetic resonance imaging (MRI-EMA)	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
Threat by MS	baseline, 2 weeks	Visual analogue scale to assess anxiety associated with disease progression (min. 0, max. 100; higher values indicate higher subjective threat)
Hospital Anxiety and Depression Scale (HADS)	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)
Control preference scale (CPS)	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)
Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)	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)

Trial Locations

Locations (1)

University Medical Centre Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany