Fatigue After STroke Educational Recovery trial (FASTER)

Not Applicable

Completed

• Conditions: post-stroke fatigue; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12619000626167
• Lead Sponsor: Auckland University of Technology

Brief Summary

Results are not yet available.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Study Completion: 2022-06-14
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible to take part in the study, potential participants must meet the following criteria:
(a) CT/MRI confirmed stroke to enable exclusion of stroke-mimic conditions;
(b) clinically significant fatigue at 3 to 24-months after stroke;
(c) residing in the study areas (Auckland, Waikato) to ensure feasibility;
(d) ability to converse in English to support understanding of group discussions and materials; and
(e) able to provide informed consent.

Exclusion Criteria

Pre-stroke fatigue, given differing aetiology requiring a different intervention approach; significant cognitive (MMSE <23 or Montreal Cognitive Assessment <26) or behavioural impairments (e.g. agitation, major depressive criteria measured by the CES-D revised - depression scale); significant disability (mRS 4-5) due to high dependence for basic Acitivities of Daily Living making some Fatigue Severity Scale (FSS) items not applicable (i.e. ‘my fatigue prevents sustained physical functioning) making it difficult to accurately detect changes in fatigue; identified causes of chronic fatigue (e.g. sleep apnea); medical instability, or other health condition (e.g. dementia, drug/alcohol abuse) that would preclude full participation; and participation in another clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1 (Primary objective) - to assess the effectiveness of the FMG intervention on subjective experiences of PSF severity immediately after the intervention (6-weeks) compared to a UC usual care group using Fatigue Severity Scale - 9. [Immediately after the intervention (6-weeks)];to assess the effectiveness of the FMG intervention on subjective experiences of PSF dimensionality immediately after the intervention (6-weeks) compared to a Usual Care (UC) group using the Multidimensional Fatigue Inventory - 20.[immediately after the intervention (6-weeks)]