Fatigue After Stroke Educational Recovery Program: A Prospective, Phase III, Randomized Controlled Trial

Abstract

BACKGROUND: Poststroke fatigue affects ≈50% of patients with stroke, causing significant personal, societal, and economic burden. In the FASTER (Fatigue After Stroke Educational Recovery) study, we assessed a group-based educational intervention for poststroke fatigue.

METHODS AND RESULTS: Two hundred patients with clinically significant fatigue were included and randomized to either a general stroke education control or fatigue management group (FMG) intervention and assessed at baseline, 6 weeks, and 3 months. The FMG involved weekly psychoeducation sessions over 6 weeks. Coprimary outcomes were the Fatigue Severity Scale and Multidimensional Fatigue Inventory-20 total scores. Adjusted mean total Fatigue Severity Scale scores at 6 weeks (primary end point) were nearly identical for the education control and FMG groups. The adjusted mean difference between treatment groups was -0.13 (SE, 1.4; P=0.92) at 6 weeks and 1.67 (SE, 1.4; P=0.26) at 3 months. Although there were no significant effects, Fatigue Severity Scale outcomes were in the direction of a treatment effect based on the estimated change. Adjusted mean total Multidimensional Fatigue Inventory-20 scores at 6 weeks (primary end point) were similar for the education control and FMG groups. The adjusted mean difference between treatment groups was -0.91 (SE, 1.54; P=0.55) at 6 weeks and -1.26 (SE, 1.8; P=0.49) at 3 months. Both groups had similar secondary outcomes (eg, Multidimensional Fatigue Inventory-20 subscales, sleep, pain, mood, quality of life) at 6 weeks and 3 months.

CONCLUSIONS: We found no evidence of significant group-level benefits of FMG over and above general stroke education. Educational group-based interventions for poststroke fatigue should continue to be refined and examined, including consideration of potential impacts at an individual level.

REGISTRATION: URL: https://www.anzctr.org.au/; UnIque identifier: ACTRN12619000626167.