Methodology of the Fatigue After STroke Educational Recovery (FASTER) Group Randomised Controlled Trial
Barker-Collo, SL; Krishnamurthi, R; Ikeda, T; Te Ao, B; Green, G; Rathnasabapathy, Y; Feigin, VL; De Silva, S; Jones, K
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RATIONALE: Post-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. AIMS: FASTER will determine if educational CBT Fatigue Management Group (FMG) reduces subjective fatigue in adults post-stroke. DESIGN: Prospective, 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. OUTCOMES: Primary 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. DISCUSSION: FASTER will determine whether FMG reduces fatigue post-stroke.Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).