Understanding Magnetic Resonance Imaging in Multiple Sclerosis
NCT ID: NCT03872583
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-03-15
2022-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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.
Understanding MRI in MS (website)
Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Christoph Heesen, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis
Locations
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University Medical Centre Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
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.
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.
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.
Schiffmann I, Freund M, Vettorazzi E, Stellmann JP, Heyer-Borchelt S, D'Hooghe M, Haussler V, Rahn AC, Heesen C. Assessing the effect of an evidence-based patient online educational tool for people with multiple sclerosis called UMIMS-understanding magnetic resonance imaging in multiple sclerosis: study protocol for a double-blind, randomized controlled trial. Trials. 2020 Dec 9;21(1):1008. doi: 10.1186/s13063-020-04855-5.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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PV5722
Identifier Type: -
Identifier Source: org_study_id
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