Understanding Magnetic Resonance Imaging in Multiple Sclerosis (UMIMS)
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| ClinicalTrials.gov Identifier: NCT03872583 |
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Recruitment Status :
Recruiting
First Posted : March 13, 2019
Last Update Posted : February 2, 2021
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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 |
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 (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 : | July 2021 |
| Estimated Study Completion Date : | July 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Understanding MRI in MS (website)
Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis. |
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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).
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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. |
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Christoph Heesen, Prof. | +49 7410 ext 53776 | heesen@uke.de | |
| Contact: Insa Schiffmann, Dr. | +49 152 22815796 | i.schiffmann@uke.de |
| Germany | |
| University Medical Centre Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Insa Schiffmann, Dr. i.schiffmann@uke.de | |
| Principal Investigator: | Christoph Heesen, Prof. | University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT03872583 |
| Other Study ID Numbers: |
PV5722 |
| First Posted: | March 13, 2019 Key Record Dates |
| Last Update Posted: | February 2, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Patient education Disease-specific knowledge Shared decision making |
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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |