A Pragmatic Parallel Arm Multi-centre Randomised Controlled Trial to Assess the Effectiveness and Cost-effectiveness of a Group-based Fatigue Management Programme (FACETS) for People with Multiple Sclerosis

Overview

Journal J Neurol Neurosurg Psychiatry

Publisher BMJ Publishing Group

Specialties Neurology
Neurosurgery
Psychiatry

Date 2013 May 23

PMID 23695501

Citations 47

Authors

Sarah Thomas

Peter W Thomas

Paula Kersten

Rosemary Jones

Colin Green

Alison Nock

Vicky Slingsby

Angela Davies Smith

Roger Baker

Kathleen T Galvin

Charles Hillier

Affiliations

Soon will be listed here.

Abstract

Background: Fatigue is a common and troubling symptom for people with multiple sclerosis (MS).

Aim: To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).

Methods: Three-centre parallel arm randomised controlled trial with economic evaluation. Patients 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 outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire).

Results: Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue.

Conclusions: FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.

Trial Registration: Current Controlled Trials ISRCTN76517470.

Citing Articles

Linking Pathogenesis to Fall Risk in Multiple Sclerosis.

Patel J, Fraix M, Agrawal D Arch Intern Med Res. 2025; 8(1):36-47.

PMID: 40041760 PMC: 11879276. DOI: 10.26502/aimr.0194.

Improvement in depressive symptoms is associated with sustained improvement in fatigue impact in adults with multiple sclerosis.

Knowles L, Mistretta E, Arewasikporn A, Hugos C, Cameron M, Haselkorn J Mult Scler Relat Disord. 2024; 92():106158.

PMID: 39577297 PMC: 11737376. DOI: 10.1016/j.msard.2024.106158.

A systematic review of the impact of therapeutic education programs on the quality of life of people with Multiple Sclerosis.

Raji I, El Harch I, Ragala M, Berraho M, Nejjar F, Belahsen M Health Promot Perspect. 2024; 14(2):97-108.

PMID: 39291039 PMC: 11403335. DOI: 10.34172/hpp.42619.

Education for fatigue management in people with multiple sclerosis: Systematic review and meta-analysis.

Wendebourg M, Poettgen J, Finlayson M, Gonzalez-Lorenzo M, Heesen C, Kopke S Eur J Neurol. 2024; 31(12):e16452.

PMID: 39225447 PMC: 11555147. DOI: 10.1111/ene.16452.

Perspectives on fatigue management among veterans living with multiple sclerosis.

Knowles L, Yang B, Mata-Greve F, Turner A Mult Scler Relat Disord. 2024; 88:105716.

PMID: 38880030 PMC: 11617002. DOI: 10.1016/j.msard.2024.105716.

References

Schwartz C, Zeng Q, Retzlaff P . Measuring self-efficacy in people with multiple sclerosis: a validation study. Arch Phys Med Rehabil. 1996; 77(4):394-8. DOI: 10.1016/s0003-9993(96)90091-x. View

Krupp L, Larocca N, Steinberg A . The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989; 46(10):1121-3. DOI: 10.1001/archneur.1989.00520460115022. View

Schwartz J, Jandorf L, Krupp L . The measurement of fatigue: a new instrument. J Psychosom Res. 1993; 37(7):753-62. DOI: 10.1016/0022-3999(93)90104-n. View

Zigmond A, SNAITH R . The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983; 67(6):361-70. DOI: 10.1111/j.1600-0447.1983.tb09716.x. View

van Kessel K, Moss-Morris R . Understanding multiple sclerosis fatigue: a synthesis of biological and psychological factors. J Psychosom Res. 2006; 61(5):583-5. DOI: 10.1016/j.jpsychores.2006.03.006. View

Manca A, Hawkins N, Sculpher M . Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2004; 14(5):487-96. DOI: 10.1002/hec.944. View

Mathiowetz V, Matuska K, Finlayson M, Luo P, Chen H . One-year follow-up to a randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Int J Rehabil Res. 2007; 30(4):305-13. DOI: 10.1097/MRR.0b013e3282f14434. View

Bauer D, Sterba S, Hallfors D . Evaluating Group-Based Interventions When Control Participants Are Ungrouped. Multivariate Behav Res. 2010; 43(2):210-236. PMC: 2853949. DOI: 10.1080/00273170802034810. View

Costello K, Harris C . Differential diagnosis and management of fatigue in multiple sclerosis: considerations for the nurse. J Neurosci Nurs. 2003; 35(3):139-48. DOI: 10.1097/01376517-200306000-00003. View

10.

Dolan P . Modeling valuations for EuroQol health states. Med Care. 1997; 35(11):1095-108. DOI: 10.1097/00005650-199711000-00002. View

11.

Thomas P, Thomas S, Kersten P, Jones R, Nock A, Slingsby V . Multi-centre parallel arm randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based cognitive behavioural approach to managing fatigue in people with multiple sclerosis. BMC Neurol. 2010; 10:43. PMC: 2905353. DOI: 10.1186/1471-2377-10-43. View

12.

Hawton A, Green C, Telford C, Zajicek J, Wright D . Using the Multiple Sclerosis Impact Scale to estimate health state utility values: mapping from the MSIS-29, version 2, to the EQ-5D and the SF-6D. Value Health. 2012; 15(8):1084-91. DOI: 10.1016/j.jval.2012.07.007. View

13.

Thomas S, Thomas P, Nock A, Slingsby V, Galvin K, Baker R . Development and preliminary evaluation of a cognitive behavioural approach to fatigue management in people with multiple sclerosis. Patient Educ Couns. 2009; 78(2):240-9. DOI: 10.1016/j.pec.2009.07.001. View

14.

Hann D, Jacobsen P, Azzarello L, Martin S, Curran S, Fields K . Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998; 7(4):301-10. DOI: 10.1023/a:1024929829627. View

15.

Opara J, Jaracz K, Brola W . Quality of life in multiple sclerosis. J Med Life. 2011; 3(4):352-8. PMC: 3019078. View

16.

Boutron I, Moher D, Altman D, Schulz K, Ravaud P . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008; 148(4):295-309. DOI: 10.7326/0003-4819-148-4-200802190-00008. View

17.

Branas P, Jordan R, Fry-Smith A, Burls A, Hyde C . Treatments for fatigue in multiple sclerosis: a rapid and systematic review. Health Technol Assess. 2000; 4(27):1-61. View

18.

Altman D, Dore C . Randomisation and baseline comparisons in clinical trials. Lancet. 1990; 335(8682):149-53. DOI: 10.1016/0140-6736(90)90014-v. View

19.

Goligher E, Pouchot J, Brant R, Kherani R, Avina-Zubieta J, Lacaille D . Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosus. J Rheumatol. 2008; 35(4):635-42. View

20.

Hemmett L, Holmes J, Barnes M, Russell N . What drives quality of life in multiple sclerosis?. QJM. 2004; 97(10):671-6. DOI: 10.1093/qjmed/hch105. View