RESUMO
RATIONALE: Post-stroke fatigue affects up to 92% of stroke survivors, causing significant burden. Educational cognitive behavioral therapy fatigue groups show positive results in other health conditions. AIMS: FASTER will determine if educational cognitive behavioral therapy fatigue management group 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, six weeks, and three months post-program 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 three months. OUTCOMES: Primary outcomes are self-reported fatigue severity and dimensionality (i.e. types of fatigue experienced - physical, psychological and/or cognitive) post-intervention (six weeks). Secondary outcomes include subjective fatigue at three 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 fatigue management group reduces fatigue post-stroke.Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).
