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

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 clinica...

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Published in:Multiple sclerosis 2014-08, Vol.20 (9), p.1234-1243
Main Authors: Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Martinelli, V, Solari, A, Pucci, E, Messmer Uccelli, M, Ferrari, G, Martini, F, D’Annunzio, G, Farina, D, Travaglini, D, Pietrolongo, E, Onofrj, M, Torri Clerici, V, Bonanno, S, Brambilla, L, Radaelli, M, Messina, J, Comi, G, Tortorella, C, Luciannatelli, E, Senesi, C, Tsantes, E, Conti, MZ, Rottoli, MR, Bellantonio, P, Fischetti, M, Fantozzi, R, Pala, A, Traccis, S, Di Battista, G, Bianchi, M, Benedetti, MD, 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, Policlinico G., Russo, M, Vita, G, Immovilli, P
Format: Article
Language:English
Subjects:
Adolescent
Adult
Biological and medical sciences
Comprehension
Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
Female
Health Knowledge, Attitudes, Practice
Health Literacy
Humans
Immunomodulators
Internet
Interviews as Topic
Italy
Male
Medical sciences
Middle Aged
Multiple Sclerosis - diagnosis
Multiple Sclerosis - physiopathology
Multiple Sclerosis - psychology
Multiple Sclerosis - therapy
Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
Neurology
Patient Education as Topic - methods
Patient Satisfaction
Pharmacology. Drug treatments
Prospective Studies
Surveys and Questionnaires
Treatment Outcome
Young Adult
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Summary: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.
ISSN:1352-4585
1477-0970
DOI:10.1177/1352458513519180