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

Autor: Jan-Patrick Stellmann, Susanne Heyer-Borchelt, Eik Vettorazzi, Vivien Häußler, Magalie Freund, Marie B. D'hooghe, Christoph Heesen, Insa Schiffmann, Anne Christin Rahn
Přispěvatelé: Centre d'Exploration Métabolique par Résonance Magnétique [Marseille] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE), Clinical sciences, Neuroprotection & Neuromodulation, Neurology, Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - APHM] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Evidence-based practice
Neuroscience(all)
Medicine (miscellaneous)
Pilot Projects
multiple sclerosis
Autonomy preferences
Process evaluation
law.invention
Study Protocol
03 medical and health sciences
Evidence-based patient information
0302 clinical medicine
Physical medicine and rehabilitation
Double-Blind Method
Randomized controlled trial
law
Surveys and Questionnaires
Intervention (counseling)
medicine
Clinical endpoint
Humans
magnetic resonance imaging
Pharmacology (medical)
030212 general & internal medicine
Risk knowledge
Shared decision-making
Randomized Controlled Trials as Topic
Disease-specific knowledge
Protocol (science)
lcsh:R5-920
medicine.diagnostic_test
business.industry
Multiple sclerosis
Magnetic resonance imaging
medicine.disease
3. Good health
Randomized Controlled Trial
Anxiety
medicine.symptom
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Zdroj: Trials
Trials, BioMed Central, 2020, 21 (1), ⟨10.1186/s13063-020-04855-5⟩
Trials, Vol 21, Iss 1, Pp 1-11 (2020)
Trials, 2020, 21 (1), ⟨10.1186/s13063-020-04855-5⟩
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04855-5⟩
Popis: Background While magnetic resonance imaging (MRI) plays a major role in the lives of people with multiple sclerosis (pwMS), studies have shown that MRI-specific knowledge in pwMS is limited. Moreover, poor knowledge was associated with negative feelings towards MRI (e.g. anxiety concerning MRI scan). Because information sources about MRI in MS for pwMS are not available, we designed and evaluated an evidence-based online educational platform about MRI in MS called “Understanding MRI in MS” (UMIMS). Based on a pilot study in n= 79 subjects, an educational intervention was found to be feasible and effective. We hypothesize that MRI-specific knowledge can be increased by using UMIMS and that, subsequently, negative feelings towards MRI will be reduced and shared decision-making competences increased. Methods This randomized, controlled, double-blinded trial (RCT) will recruit n = 120 pwMS. The intervention group will receive access to UMIMS. The control group will get access to a specifically developed control website, which visually imitates UMIMS and contains the standard information available by several MS self-help organizations. The change in MRI-specific knowledge assessed via the MRI-risk knowledge questionnaire (MRI-RIKNO) after the intervention is the primary endpoint at 2 weeks. Several secondary endpoints will be assessed at different timepoints throughout the study, e.g. emotions towards MRI, autonomy preferences, threat by MS and shared decision-making competences. The study includes a process evaluation. Discussion The aim of this RCT is to prove that access to an education tool on MRI in MS will increase pwMS’ MRI-specific knowledge and enhance shared decision-making when discussing decisions involving MRI results during patient-physician encounters. Trial registration Clinicaltrials.gov NCT03872583. Registered on 13 March 2019.
Databáze: OpenAIRE
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