title: Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial.
abstract: The SIMS-Trial showed that the 'Sapere Migliora' information aid (IA) for newly diagnosed people with multiple sclerosis (PwMS) effectively improved patient knowledge and satisfaction with care.
  
  
  
  The objectives of this paper are to assess the effectiveness of the IA in clinical practice and to compare the whole IA with the take-home booklet/website component alone.
  
  
  
  After updating the IA and replacing the CD with a website, a prospective, open-label non-randomised controlled trial compared the whole IA (group A, five SIMS-Trial centres) to take-home (group B, 16 centres). One month after the intervention, participants completed the MS Knowledge Questionnaire (MSKQ), care satisfaction questionnaire (COSM-R) (primary study outcomes), Hospital and Anxiety Depression Scale, and ad hoc questionnaire appraising the IA.
  
  
  
  We enrolled 159 newly diagnosed PwMS (May 2012-March 2013). Drop-outs were four of 77 (5%, group A) and 11/82 (13%, group B). Primary endpoint (highest tertile both for MSKQ and COSM-R section 2 scores) was achieved by 38/77 (49%) group A and 33/82 (40%) group B (p = 0.25). Attainment of secondary outcomes was also similar between groups.
  
  
  
  This study shows that the entire IA is not superior to the booklet/website alone, and that both are comparable in efficacy to the intervention arm of the SIMS-Trial.
  
  
  
  ISRCTN78940214.
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Giordano
authors.affiliation: Department of Neuroscience and Imaging, University G. d'Annunzio of Chieti-Pescara, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: Department of Neuroimmunology, Foundation IRCCS Neurological Institute C. Besta, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Confalonieri
authors.affiliation: Department of Neurosciences, Neurology Unit, University of Parma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Granella
authors.affiliation: Division of Epidemiology and Biostatistics, European Institute of Oncology, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Radice
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Trojano
authors.affiliation: Department of Neurology, Scientific Institute Hospital San Raffaele, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Italy solari@istituto-besta.it.
authors.forename: A
authors.initials: A
authors.lastname: Solari
mesh_terms: D000293:Adolescent; D000328:Adult; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006801:Humans; D020407:Internet; D007407:Interviews as Topic; D007558:Italy; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods*; D017060:Patient Satisfaction; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
keywords: Multiple sclerosis; clinical practice; complex health intervention; disease knowledge; information aid; patient satisfaction