The feasibility and acceptability of conducting a randomised controlled trial evaluating a healthcare professional-supported, self-management intervention for people suffering from fatigue after critical illness.
Yijun Yu, Sophie Eleanor Brown, Akshay Shah, Wladyslawa Czuber-Dochan, Suzanne Bench, Clare Martin, Georgia Cook, David McWilliams, Emma Hedley, Najib Rahman, Rebecca Langley, Louise Stayt
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引用次数: 0
Abstract
Background: Fatigue is a common problem that significantly affects intensive care unit (ICU) survivors' physical, psychological, and social functioning. ICU survivors often experience a loss of self-worth and identity, struggle to return to their normal roles, and face ongoing challenges with cognitive and emotional recovery. Despite its profound impact, there are limited rehabilitation interventions targeting this population. This research aims to evaluate the acceptability of implementing the Fatigue After CriTical illness (FACT) self-management intervention into usual care for patients experiencing fatigue after critical illness and the feasibility of the intervention for a future clinical trial.
Methods: This is a multicentre, open-label, feasibility randomised controlled trial (RCT) with an embedded qualitative evaluation, conducted across. Seventy participants recruited from three United Kingdom (UK) National Health Service (NHS) Trusts will be randomised either to the FACT self-management intervention following hospital discharge, which focuses on fatigue management, goal setting, and personal action planning, in addition to usual care, or to a control group receiving usual care alone. The intervention will be accessible for six months and will include a 30-min phone or video call with an ICU follow-up healthcare professional (HCP) in the third month. HCPs will attend an online training session and follow a protocol to guide patients in goal setting. Outcome assessments will occur at baseline, three months, and six months post-randomisation to evaluate feasibility and acceptability. Semi-structured interviews with patients and HCPs will explore their experiences and acceptability outcomes at 6 months.
Discussion: This study aims to provide insights into the feasibility and acceptability of the FACT intervention, with the goal of improving fatigue management among survivors of critical illness. Preliminary findings will inform the design of a larger-scale RCT to evaluate its effectiveness in enhancing recovery from critical illness in patients who are experiencing fatigue.
Trial registration: Study ID: ISRCTN1381359 . Date registered: 01/04/2025.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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