A Giordano1, A Lugaresi2, P Confalonieri3, F Granella4, D Radice5, M Trojano6, V Martinelli7, A Solari8. 1. Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Italy. 2. Department of Neuroscience and Imaging, University G. d'Annunzio of Chieti-Pescara, Italy. 3. Department of Neuroimmunology, Foundation IRCCS Neurological Institute C. Besta, Italy. 4. Department of Neurosciences, Neurology Unit, University of Parma, Italy. 5. Division of Epidemiology and Biostatistics, European Institute of Oncology, Italy. 6. Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Italy. 7. Department of Neurology, Scientific Institute Hospital San Raffaele, Italy. 8. Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Italy solari@istituto-besta.it.
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.
RCT Entities:
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.
Authors: Christian Philipp Kamm; L Barin; C Gobbi; C Pot; P Calabrese; A Salmen; L Achtnichts; J Kesselring; M A Puhan; V von Wyl Journal: J Neurol Date: 2019-10-08 Impact factor: 4.849
Authors: Anne Christin Rahn; Alessandra Solari; Heleen Beckerman; Richard Nicholas; David Wilkie; Christoph Heesen; Andrea Giordano Journal: Int J MS Care Date: 2020-12-28
Authors: C Heesen; J Kasper; K Fischer; S Köpke; A Rahn; I Backhus; J Poettgen; L Vahter; J Drulovic; A Van Nunen; Y Beckmann; K Liethmann; A Giordano; G Fulcher; A Solari Journal: PLoS One Date: 2015-10-02 Impact factor: 3.240