Understanding Magnetic Resonance Imaging in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— UMIMS  

Official title:

Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872583
• Other study ID #: PV5722
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• Understanding MRI in MS (website)
Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.
• 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.

Locations

Country	Name	City	State
Germany	University Medical Centre Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Sanofi

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Boeije HR, Janssens AC. 'It might happen or it might not': how patients with multiple sclerosis explain their perception of prognostic risk. Soc Sci Med. 2004 Aug;59(4):861-8. doi: 10.1016/j.socscimed.2003.11.040. — View 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. — View Citation

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655. — View Citation

Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. — View 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. — View Citation

Heesen C, Kasper J, Fischer K, Kopke S, Rahn A, Backhus I, Poettgen J, Vahter L, Drulovic J, Van Nunen A, Beckmann Y, Liethmann K, Giordano A, Fulcher G, Solari A; AutoMS-group. Risk Knowledge in Relapsing Multiple Sclerosis (RIKNO 1.0)--Development of an Outcome Instrument for Educational Interventions. PLoS One. 2015 Oct 2;10(10):e0138364. doi: 10.1371/journal.pone.0138364. eCollection 2015. — View Citation

Heesen C, Kasper J, Kopke S, Richter T, Segal J, Muhlhauser I. Informed shared decision making in multiple sclerosis--inevitable or impossible? J Neurol Sci. 2007 Aug 15;259(1-2):109-17. doi: 10.1016/j.jns.2006.05.074. Epub 2007 Apr 2. — View 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. Erratum In: PLoS One. 2012;7(6). doi:10.1371/annotation/3e489f03-e7e7-4b41-827e-caa85bb06466. — View Citation

Riechel C, Alegiani AC, Kopke S, Kasper J, Rosenkranz M, Thomalla G, Heesen C. Subjective and objective knowledge and decisional role preferences in cerebrovascular patients compared to controls. Patient Prefer Adherence. 2016 Aug 2;10:1453-60. doi: 10.2147/PPA.S98342. eCollection 2016. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)	15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)	2 weeks
Secondary	Emotions and attitude towards magnetic resonance imaging (MRI-EMA)	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	Baseline, 2 weeks
Secondary	Control preference scale (CPS)	Scale to assess autonomy preferences during medical decisions (5 categories between complete autonomy and paternalistic decision making as the extremes)	Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)
Secondary	Threat by MS	Visual analogue scale to assess anxiety associated with disease progression (min. 0, max. 100; higher values indicate higher subjective threat)	baseline, 2 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	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)	Baseline, 2 weeks
Secondary	Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)	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)	after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)