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Open Access Research article

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 Thomas1, Sarah Thomas1*, Paula Kersten2, Rosemary Jones3, Vicky Slingsby4, Alison Nock4, Angela Davies Smith3, Roger Baker1, Kathleen T Galvin5 and Charles Hillier4

Author Affiliations

1 Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth BH1 3LT, UK

2 Person Centred Research Centre, School of Rehabilitation and Occupation Studies, Auckland University of Technology, Auckland, New Zealand

3 MS Research Unit, Bristol and Avon MS Clinical Centre, Frenchay Hospital, Bristol BS16 1LE, UK

4 Dorset MS Service, Poole Hospital NHS Foundation Trust, Poole BH15 2JB, UK

5 Faculty of Health and Social Care, Hull University, Hull HU6 7RX, UK

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BMC Neurology 2014, 14:109  doi:10.1186/1471-2377-14-109

Published: 19 May 2014

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