EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial.

Abstract

RATIONALE\nPost-stroke fatigue (PSF) affects up to 92% of stroke survivors, causing significant burden. Educational Cognitive Behavioural Therapy (CBT) fatigue groups show positive results in other health conditions.\n\n\nAIMS\nFASTER will determine if educational CBT Fatigue Management Group (FMG) reduces subjective fatigue in adults post-stroke.\n\n\nDESIGN\nProspective, multi-centre, two-arm, single-blind, phase III RCT (parallel, superiority design), with blinded assessments at baseline, 6-weeks, and 3-months post-programme commencement. With n=200 (100 per group, 20% drop-out) the trial will have 85% power (2-sided, p= 0.05) to detect minimally clinically important differences of 0.60 (SD=1.27) in Fatigue severity scale and 1.70 points (SD=3.6) in Multidimensional Fatigue Inventory-20 at 3-months.\n\n\nOUTCOMES\nPrimary outcomes are self-reported fatigue severity and dimensionality (i.e., types of fatigue experienced - physical, psychological and/or cognitive) post-intervention (6-weeks). Secondary outcomes include subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up.\n\n\nDISCUSSION\nFASTER will determine whether FMG reduces fatigue post-stroke.Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).