Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial. (August 2014)

• Record Type: Journal Article
• Authors: Giordano, A; Lugaresi, A; Confalonieri, P; Granella, F; Radice, D; Trojano, M; Martinelli, V; Solari, A
• Other Names: Giordano A non-byline-author.; Martinelli V non-byline-author.; Lugaresi A non-byline-author.; Pucci E non-byline-author.; Granella F non-byline-author.; Trojano M non-byline-author.; Solari A non-byline-author.; Martinelli V non-byline-author.; Pucci E non-byline-author.; Messmer Uccelli M non-byline-author.; Lugaresi A non-byline-author.; Giordano A non-byline-author.; Granella F non-byline-author.; Solari A non-byline-author.; Giordano A non-byline-author.; Ferrari G non-byline-author.; Martini F non-byline-author.; Solari A non-byline-author.; Radice D non-byline-author.; D'Annunzio G non-byline-author.; Lugaresi A non-byline-author.; Farina D non-byline-author.; Travaglini D non-byline-author.; Pietrolongo E non-byline-author.; Onofrj M non-byline-author.; Torri Clerici V non-byline-author.; Bonanno S non-byline-author.; Brambilla L non-byline-author.; Confalonieri P non-byline-author.; Martinelli V non-byline-author.; Radaelli M non-byline-author.; Messina J non-byline-author.; Comi G non-byline-author.; Tortorella C non-byline-author.; Luciannatelli E non-byline-author.; Trojano M non-byline-author.; Senesi C non-byline-author.; Tsantes E non-byline-author.; Granella F non-byline-author.; Conti MZ non-byline-author.; Rottoli MR non-byline-author.; Bellantonio P non-byline-author.; Fischetti M non-byline-author.; Fantozzi R non-byline-author.; Pala A non-byline-author.; Traccis S non-byline-author.; Di Battista G non-byline-author.; Bianchi M non-byline-author.; Benedetti MD non-byline-author.; Gaetani L non-byline-author.; Di Filippo M non-byline-author.; Carolei A non-byline-author.; Totaro R non-byline-author.; Lanzillo R non-byline-author.; Brescia Morra V non-byline-author.; Coppola R non-byline-author.; Cottone S non-byline-author.; Chiavazza C non-byline-author.; Cavalla P non-byline-author.; Leonardi C non-byline-author.; Aguglia U non-byline-author.; Ziuliani C non-byline-author.; Valla P non-byline-author.; Sasanelli F non-byline-author.; Valentino P non-byline-author.; Quattrone A non-byline-author.; Martino Policlinico G. non-byline-author.; Russo M non-byline-author.; Vita G non-byline-author.; Immovilli P non-byline-author.;
• Is Part Of: Multiple sclerosis. Volume 20:Number 9(2014)
• Page Start: 1234
• Page End: 1243
• Publication Date: 2014-08
• Subjects: Multiple sclerosis -- complex health intervention -- information aid -- disease knowledge -- patient satisfaction -- clinical practice; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458513519180
• Languages: English
• ISSNs: 1352-4585

Abstract

Background: 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. Objectives: 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. Methods: 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. Results: 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. Conclusions: 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. Trial registration number: ISRCTN78940214.