My jaw dropped to the floor on this one. SUBJECTIVE FATIGUE? You're just trying to make patients 'think' they are better by doing nothing concrete. What fucking objective bullshit.
EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial
Abstract
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.(It does nothing of the sort.)
Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).
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