Remote multicomponent rehabilitation compared to standard care for survivors of critical illness after hospital discharge (iRehab): a protocol for a randomised controlled assessor-blind clinical and cost-effectiveness trial.

Abstract

Background: The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life. We hypothesise that for people discharged after intensive care unit (ICU) for a critical illness, a six-week remote multicomponent rehabilitation intervention improves health-related quality of life, physical function, fatigue, mood, and other health-related outcomes after eight weeks, compared to standard care.

Methods: This is a pragmatic, randomised controlled, open-label, assessor blind, multicentre, clinical and cost effectiveness trial with internal pilot and embedded process evaluation. Recruitment will take place in NHS hospitals across the UK. Adults (n=428: control n= 197; intervention: n=231) within 12 weeks of discharge from hospital following an ICU admission for critical illness, requiring mechanical ventilation ≥48hours will be recruited.The intervention is a six week multicomponent, structured, rehabilitation programme, delivered remotely by a trained intervention team. The intervention includes four components: weekly symptom management; targeted exercise; psychological support, and peer support and information. The control group will receive standard NHS care.The primary outcome is Health-related quality of life (HRQoL) at eight weeks post-randomisation measured using the EQ-5D-5L. Secondary outcomes are: HRQoL (six months), physical function, fatigue, anxiety and depression, healthcare resource use at eight weeks and six months and intervention acceptability.

Conclusions: This trial will test a centrally delivered mulitcomponent rehabilitation intervention for survivors of critical illness, irrespective of geographic location or critical illness diagnosis.

Trial registration: The trial is registered (04.07.2022) with the International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN11266403 https://doi.org/10.1186/ISRCTN11266403.