Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice

A late-phase controlled trial

A. Giordano, A. Lugaresi, P. Confalonieri, F. Granella, D. Radice, M. Trojano, V. Martinelli, A. Solari

Research output: Contribution to journalArticle

9 Citations (Scopus)

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 que tionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012March 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) wasm 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.

Original languageEnglish
Pages (from-to)1234-1243
Number of pages10
JournalMultiple Sclerosis Journal
Volume20
Issue number9
DOIs
Publication statusPublished - 2014

Fingerprint

Multiple Sclerosis
Pamphlets
Group Homes
Patient Satisfaction
Anxiety
Outcome Assessment (Health Care)
Depression
Surveys and Questionnaires
Non-Randomized Controlled Trials

Keywords

  • clinical practice
  • complex health intervention
  • disease knowledge
  • information aid
  • Multiple sclerosis
  • patient satisfaction

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

@article{b029bab62ad14bd88ef42c3a2eeaa2ec,
title = "Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: A late-phase controlled trial",
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 que tionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012March 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) wasm 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.",
keywords = "clinical practice, complex health intervention, disease knowledge, information aid, Multiple sclerosis, patient satisfaction",
author = "A. Giordano and A. Lugaresi and P. Confalonieri and F. Granella and D. Radice and M. Trojano and V. Martinelli and A. Solari",
year = "2014",
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T1 - Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice

T2 - A late-phase controlled trial

AU - Giordano, A.

AU - Lugaresi, A.

AU - Confalonieri, P.

AU - Granella, F.

AU - Radice, D.

AU - Trojano, M.

AU - Martinelli, V.

AU - Solari, A.

PY - 2014

Y1 - 2014

N2 - 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 que tionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012March 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) wasm 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.

AB - 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 que tionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012March 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) wasm 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.

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