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Implementation of the ‘Sapere Migliora’ information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial

2014; SAGE Publishing; Volume: 20; Issue: 9 Linguagem: Inglês

10.1177/1352458513519180

1477-0970

Andrea Giordano, Alessandra Lugaresi, Paolo Confalonieri, Franco Granella, D. Radice, Maria Trojano, Vittorio Martinelli, Alessandra Solari, Andrea Giordano, Vittorio Martinelli, Alessandra Lugaresi, Eugenio Pucci, Franco Granella, Maria Trojano, Alessandra Solari, Vittorio Martinelli, Eugenio Pucci, Michele Messmer Uccelli, Alessandra Lugaresi, Andrea Giordano, Franco Granella, Alessandra Solari, Andrea Giordano, Giulia Ferrari, Fernanda Martini, Alessandra Solari, D. Radice, Giuseppe d’Annunzio, Alessandra Lugaresi, D. Farina, D. Travaglini, Erika Pietrolongo, Marco Onofrj, Valentina Torri Clerici, Silvia Bonanno, Laura Brambilla, Paolo Confalonieri, Vittorio Martinelli, Marta Radaelli, John Messina, Gıancarlo Comı, Carla Tortorella, Elena Luciannatelli, Maria Trojano, Caterina Senesi, Elena Tsantes, Franco Granella, MZ Conti, MR Rottoli, P. Bellantonio, Mariano Fischetti, Roberta Fantozzi, A Pala, S. Traccis, Giancarlo Di Battista, Maria Bianchi, Maria Donata Benedetti, Lorenzo Gaetani, Massimiliano Di Filippo, A Carolei, Rocco Totaro, Roberta Lanzillo, Vincenzo Brescia Morra, Rosa Coppola, Salvatore Cottone, Carlotta Chiavazza, Paola Cavalla, C. Leonardi, Umberto Aguglia, C Ziuliani, P Valla, Francesco Sasanelli, Paola Valentino, Aldo Quattrone, Policlinico G. Martino, Margherita Russo, Giuseppe Vita, Paolo Immovilli,

Family Support in Illness

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.