Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Clinically Isolated Syndrome
  • Multiple Sclerosis
  • Multiple Sclerosis - Relapsing Remitting
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, controlled, double-blind trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Participants, physicians, outcome assessors and investigator will be blinded.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 informati...

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.

Tracking Information

NCT #
NCT03872583
Collaborators
Sanofi
Investigators
Principal Investigator: Christoph Heesen, Prof. University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis