NCT03872583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

January 25, 2019

Last Update Submit

December 27, 2023

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingClinically Isolated Syndrome

Keywords

Patient educationDisease-specific knowledgeShared decision making

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Emotions and attitude towards magnetic resonance imaging (MRI-EMA)

    Baseline, 2 weeks

  • Control preference scale (CPS)

    Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)

  • Threat by MS

    baseline, 2 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline, 2 weeks

  • Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)

    after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)

Study Arms (2)

Understanding MRI in MS (website)

EXPERIMENTAL

Participants will receive access to a newly developed, innovative, interactive and evidence-based education tool about magnetic resonance imaging in multiple sclerosis.

Other: Understanding MRI in MS (website)

Control website

ACTIVE COMPARATOR

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).

Other: Control website

Interventions

Understanding MRI in MS (website)OTHER

Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.

Understanding MRI in MS (website)
Control websiteOTHER

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.

Control website

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (11)

  • 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.

    PMID: 25415501BACKGROUND

  • 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.

    PMID: 28764895BACKGROUND

  • 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.

    PMID: 26430887BACKGROUND

  • 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.

    PMID: 17400253BACKGROUND

  • 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.

    PMID: 18824488BACKGROUND

  • 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.

    PMID: 15177841BACKGROUND

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

    PMID: 9505581BACKGROUND

  • 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.

    PMID: 27536077BACKGROUND

  • 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.

    PMID: 22514677BACKGROUND

  • 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.

    PMID: 6880820BACKGROUND

  • 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.

    PMID: 33298133DERIVED

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christoph Heesen, Prof.

    University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, physicians, outcome assessors and investigator will be blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, controlled, double-blind trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

March 13, 2019

Study Start

March 15, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations

DE(1)