One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis

Peter W. Thomas, Sarah Thomas, Paula Kersten, Rosemary Jones, V. Slingsby, A. Nock, Angela Davies Smith, Roger Baker, Kathleen Galvin, Charles Hillier

Research output: Contribution to journalArticle

Abstract

Background: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme (‘FACETS’) for managing MS-fatigue. Methods: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). Results: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (−0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES −0.24, p = 0.046). No adverse events were reported. Conclusions: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group
Original languageEnglish
JournalBMC Neurology
Volume14
DOIs
Publication statusPublished - 19 May 2014

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Multiple Sclerosis
Fatigue
Randomized Controlled Trials
Self Efficacy
Random Allocation
Quality of Life
Outcome Assessment (Health Care)

Bibliographical note

© Thomas et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Keywords

  • Randomised controlled trial
  • Multiple sclerosis
  • Fatigue
  • Intervention
  • Energy effectiveness
  • Cognitive behavioural
  • Group

Cite this

Thomas, Peter W. ; Thomas, Sarah ; Kersten, Paula ; Jones, Rosemary ; Slingsby, V. ; Nock, A. ; Smith, Angela Davies ; Baker, Roger ; Galvin, Kathleen ; Hillier, Charles. / One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. In: BMC Neurology. 2014 ; Vol. 14.
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One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. / Thomas, Peter W.; Thomas, Sarah; Kersten, Paula; Jones, Rosemary; Slingsby, V.; Nock, A.; Smith, Angela Davies; Baker, Roger; Galvin, Kathleen; Hillier, Charles.

In: BMC Neurology, Vol. 14, 19.05.2014.

Research output: Contribution to journalArticle

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T1 - One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis

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AU - Thomas, Sarah

AU - Kersten, Paula

AU - Jones, Rosemary

AU - Slingsby, V.

AU - Nock, A.

AU - Smith, Angela Davies

AU - Baker, Roger

AU - Galvin, Kathleen

AU - Hillier, Charles

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Y1 - 2014/5/19

N2 - Background: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme (‘FACETS’) for managing MS-fatigue. Methods: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). Results: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (−0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES −0.24, p = 0.046). No adverse events were reported. Conclusions: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group

AB - Background: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme (‘FACETS’) for managing MS-fatigue. Methods: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). Results: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (−0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES −0.24, p = 0.046). No adverse events were reported. Conclusions: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group Trial registration: ISRCTN76517470 Keywords: Randomised controlled trial, Multiple sclerosis, Fatigue, Intervention, Energy effectiveness, Cognitive behavioural, Group

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KW - Multiple sclerosis

KW - Fatigue

KW - Intervention

KW - Energy effectiveness

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KW - Group

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VL - 14

JO - BMC Neurology

JF - BMC Neurology

SN - 1471-2377

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