Platform Presentation The Joint Annual Meeting of the Stroke Society of Australasia (SSA) and Smartstrokes 2023

Fatigue After STroke Educational Recovery (FASTER) programme: a Prospective, Multi-centre, Single-blinded, Phase 3 Randomized Controlled Trial (#66)

Kelly Jones 1 , Rita Krishnamurthi 1 , Suzanne Barker-Collo 2 , Sulekha DeSilva 1 , Nathan Henry 3 , Irene Zeng 3 , Anja Vorster 3 , Braden TeAo 4 , Geoff Green 5 , Yogini Ratnasabapathy 6 , Valery Feigin 1
  1. National institute for Stroke and Applied Neurosciences, Auckland University of Technology, Northcote, AUCKLAND, New Zealand
  2. School of Psychology, The University of Auckland, Auckland, New Zealand
  3. Department of Biostatistics and Epidemiology, Auckland University of Technology, Auckland, New Zealand
  4. School of Population Health, The University of Auckland, Auckland, New Zealand
  5. Services for Older People, Te Whatu Ora – Health New Zealand, Counties Manukau, Auckland, New Zealand
  6. Older Adults Services and Stroke Services, Te Whatu Ora – Health New Zealand, Waitemata, Auckland, New Zealand

Background: Post-stroke fatigue (PSF) affects up to 92% of stroke patients, causing significant personal, societal, and economic burden. Global stroke guidelines recommend education and strategies to manage PSF, yet there are no proven treatments. Group-based cognitive behaviour therapy interventions for fatigue have had positive results in other health conditions (i.e., multiple sclerosis, traumatic brain injury), however, there is no evidence for post-stroke.

Aims: In FASTER (Fatigue After STroke Educational Recovery), we assessed a group-based, educational intervention for PSF compared to general stroke education alone.

Methods: FASTER was a prospective, multi-centre, two-arm, single-blinded, phase III (parallel, superiority) randomized control trial. Participants were randomized to general stroke education/control (EC; n = 100) or a fatigue management group (FMG; n = 100) intervention and assessed at baseline, 6-weeks, and 3-months. The FMG involved 60-minute weekly psychoeducation sessions over six weeks. Participants were adults with stroke in the past 3-24 months and clinically significant fatigue. Co-primary outcomes were Fatigue Severity Scale (FSS) and Multi-dimensional Fatigue Inventory-20 (MFI-20) total scores.

Results: When adjusted for significant confounders, 6-week FSS and MFI-20 group score differences were -0.13 [95% CI, -2.93-2.67], p=0.93, and 0.64 [95% CI, -0.84- 2.12], p=0.40, respectively. Across all participants, every week post-stroke was associated with a significant decrease in FSS (0.4 points, SE 0.2, p=0.02), with greater decreases in the FMG group. Every week post-stroke was associated with marginally significant increases in MFI-20 (0.2 points, SE 0.1, p=0.07), with greater increases in EC group. Both groups had similar secondary outcomes at 6-weeks and 3-months.

Conclusion: We found no evidence of significant group-level benefits of FMG over and above general stroke education, though fatigue outcomes were in the direction of a treatment effect. Educational, group-based interventions for PSF should continue to be refined and examined, including consideration of potential impacts at an individual-level.