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

The manualised group-based FACETS programme is described elsewhere [6] and is based upon a conceptual framework integrating elements from cognitive behavioural, social-cognitive, energy effectiveness, self-management and self-efficacy theories. The aim of the intervention is to help people with MS normalise their fatigue experiences, learn helpful ways of thinking about fatigue and use available energy more effectively. The intervention consists of six sessions (∼90 min duration) held weekly and facilitated in groups of 6–12 by two health professionals with experience of working with people with MS and group-work (such as occupational therapists, nurses or physiotherapists). Each session follows the same general format, namely, facilitator-delivered presentations, flipchart discussions, group activities and homework. The facilitator manual provides guidance on preparation and delivery, detailed session content, notes and suggested timings, and a checklist of facilitator objectives as well as signposts to additional resources. Sessions are delivered via PowerPoint; hence can be easily replicated. A companion participant handbook, along with existing information booklets, reinforces programme content.

FACETS was delivered in hotel meeting-room facilities, with the exception of one centre, where it was held in a rehabilitation hospital. Apart from one MS specialist nurse, facilitators were either occupational therapists or physiotherapists. Facilitators were trained to deliver the intervention at 1-day workshops and psychological advice and debriefing were available for facilitators throughout the trial.

To increase external validity, no attempt was made in the FACETS arm to restrict or control participants’ access to current local practice or to standardise it across healthcare settings or treatment arms. When we refer to the FACETS arm, participants in this arm also received current local practice.

Participants randomised to this arm of the trial received current local practice.

This could have ranged from general advice and information provision about MS-fatigue to more detailed individualised management advice from a variety of health professionals. Inevitably, there will have been variations in the exact composition of what was usually provided, within and between centres, depending on local resources and patient need. Collecting detailed information at an individual level on the type and quantity of advice received as part of current local practice was not deemed feasible. However, this real world variation increases applicability to a wider range of centres.

For those allocated to the FACETS arm outcomes were measured 1 week (baseline) before the start of the FACETS programme and 1 month (follow-up 1), 4 months (follow-up 2) and 12 months (follow-up 3) after the final session. Participants in the current local practice arm completed outcome measures within an identical time frame. Data from follow-up 1 and 2 have previously been reported [7]. In this paper we focus on reporting follow-up 3.

Primary outcomes were fatigue severity (Global Fatigue Severity (GFS) subscale of the Fatigue Assessment Instrument (FAI)), disease specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29, V.1)) and self-efficacy for managing fatigue (Multiple Sclerosis - Fatigue Self-Efficacy scale (MS-FSE)) [7,8].

Secondary outcomes included the Fatigue Symptom Inventory (FSI), the Hospital Anxiety and Depression Scale (HADS), the Medical Outcomes Short-Form Survey (SF-36, V. 2), and subscales of the MSIS-29 (V.1) and the FAI [7, 8]. All outcomes collected at 12 months were self-reported questionnaires and administered postally.

The sample size requirement was 146 participants with follow-up data based on having 85% power to detect a medium standardised effect size of 0.5 for the primary outcome measures, using a two-sided 5% significance level (see protocol for justification for this medium effect size) [8]. As a variety of fatigue measures have been used in other trials, we used standardised effect sizes to enable comparisons between them.

The intention-to-treat analyses and results for the primary outcome measures are shown in Table 2.

Results for fatigue severity and self-efficacy were similar to those at 4 months with a slight reduction in standardised effect size (SES) from −0.35 (p = 0.01) for fatigue severity to −0.29 (p = 0.06) and from 0.36 (p = 0.048) for fatigue self-efficacy to 0.34 (p = 0.09). There were significantly greater improvements on the MSIS-29 for the FACETS arm compared with the CLP arm (p = 0.046, SES = −0.24) that were not evident at 4 months.

The per protocol analysis resulted in an increased SES for the MSIS-29 (from −0.24 to −0.26 (p = 0.03)) and for the MS-FSE (from 0.34 to 0.39 (p = 0.046)). The SES for the GFS subscale was reduced from −0.29 to −0.25 (p = 0.10).

Participants in the FACETS arm were 1.5 times more likely (31% (19/62) versus 20% (14/69)) to have a clinically important improvement on the GFS (defined as an individual reduction of ≥ 0.5), although, unlike at 4 months, this was not statistically significant (p = 0.25 using chi-squared test with continuity correction).

Using the mixed model approach, the mean difference at 1 year for GFS was almost unchanged (−0.28 (−0.58, 0.02), p = 0.07), for fatigue self-efficacy was slightly higher (7 (1, 13), p = 0.02), and for the MSIS-29 slightly lower (−3.90 (−8.08, 0.28), p = 0.07).

No adverse events, as defined in the protocol, were reported.

For the MSIS-29 physical subscale (p = 0.046, SES = −0.23) and the vitality subscale of the SF-36 (p = 0.03, SES = 0.37) there was a significant difference in favour of the FACETS arm at 1 year. None of the other secondary outcomes was statistically significant. Effect sizes and significance levels were similar using the mixed model approach.