Methodology of the fatigue after stroke educational recovery group randomized controlled trial

Abstract

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).