1. Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial
- Author
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Giordano A, Martinelli V, Lugaresi A, Pucci E, Granella F, Trojano M, Solari A, Messmer Uccelli M, Ferrari G, Martini F, Radice D, D'Annunzio G, Farina D, Travaglini D, Pietrolongo E, Onofrj M, Torri Clerici V, Bonanno S, Brambilla L, Confalonieri P, Radaelli M, Messina J, Comi G, Tortorella C, Luciannatelli E, Senesi C, Tsantes E, Conti M, Rottoli M, Bellantonio P, Fischetti M, Fantozzi R, Pala A, Traccis S, Di Battista G, Bianchi M, Benedetti M, Gaetani L, Di Filippo M, Carolei A, Totaro R, Lanzillo R, Brescia Morra V, Coppola R, Cottone S, Chiavazza C, Cavalla P, Leonardi C, Aguglia U, Ziuliani C, Valla P, Sasanelli F, Valentino P, Quattrone A, Martino PG, Russo M, Vita G, Immovilli P., Giordano A, Lugaresi A, Confalonieri P, Granella F, Radice D, Trojano M, Martinelli V, Solari A, on behalf of the SIMS-Practice groupa, Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Comi, Giancarlo, on behalf of the SIMS Practice, Group, and Radaelli, Marta
- Subjects
Adult ,Male ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,Multiple Sclerosis ,Adolescent ,patient satisfaction ,Health literacy ,Group B ,law.invention ,Interviews as Topic ,Young Adult ,Patient satisfaction ,complex health intervention ,Randomized controlled trial ,Patient Education as Topic ,law ,Surveys and Questionnaires ,Multiple Sclerosi ,Clinical endpoint ,Medicine ,Humans ,Prospective Studies ,Young adult ,Prospective cohort study ,disease knowledge ,information aid ,Internet ,business.industry ,Multiple sclerosis ,multiple sclerosis ,clinical practice ,Middle Aged ,medicine.disease ,Health Literacy ,Treatment Outcome ,Neurology ,Italy ,Physical therapy ,Female ,Pamphlets ,Neurology (clinical) ,business ,Comprehension - 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.
- Published
- 2014
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