Methodology of the Fatigue After STroke Educational Recovery (FASTER) Group Randomised Controlled Trial
Date
Authors
Barker-Collo, SL
Krishnamurthi, R
Ikeda, T
Te Ao, B
Green, G
Rathnasabapathy, Y
Feigin, VL
De Silva, S
Jones, K
Supervisor
Item type
Journal Article
Degree name
Journal Title
Journal ISSN
Volume Title
Publisher
SAGE Publications
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.Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).Description
Keywords
Cognitive Behavioural, Group, Intervention, Protocol, Stroke, fatigue
Source
International Journal of Stroke. https://doi.org/10.1177/17474930211006295
Publisher's version
Rights statement
Under SAGE's Green Open Access policy, the Accepted Version of the article may be posted in the author's institutional repository and reuse is restricted to non-commercial and no derivative uses.