B ONeill, Judy M. Bradley, B; id_orcid 0000-0002-5676-5497 Connolly, Julie Bruce, Mariam Ratna, Ranjit Lall, Martin Underwood, Chen Ji, Jill Costley, Rachel Clarke, Paul Dark, O Duffy, Penelope Firshman, Nigel D. Hart, Annette Henderson, Katherine Jones, Roger Kenyon, Jason Madan, Darren Murphy, Gavin D. Perkins, Kerry Raynes, Ella Terblanche, Mandana Zanganeh, Daniel F. McAuley, iRehab Trial Investigators, Jane Snell, Sinead O'Kane, Jonathan Weblin, Denise McFarland, Jane Hedley, Kate Tantam, Sarah Varga, Catherine Donnison, Jennifer Davies, Samantha Coetzee, Keeleigh Champman, Amy Arnold, Hannah Hayter, Isabel Gonzales, Julie North, Mandeep Phull, Eriko Morino, Deborah Paripoorani, Patricia Doble, Juan Martin-Lazaro, Charlotte Tai, Ruth Wood, Tracey Hodgkiss, Kathryn Birchall, Eva Hirst, Denise Skinner, Kayode Adeniji, Estefania Trues, Cheryl Graham, F H Compton, Nicholas Truman, Lynn McDonnell, Karthhika Jeyakumar, Bethan Gibson, Daniel Law, Alicia Waite, Rebecca Chadwick, Daniel Hansen, Elizabeth Howard, Sarah Howe, Zoe van Willigen, Philip Duggleby, Anthony Rostron, Samantha Hagan, David McWilliams, Joanna Thomas, Ahmed Abdelaty, Valerie Page, Kirstin Geer, Suzahn Wilson, Martin Udberg, Anezka Pratley, Amy Charnock, Luke Ward, Ellen Knights
Importance: Evidence for remote multicomponent rehabilitation among critical care survivors is sparse. Objective: To investigate the effects of a 6-week, remote, multicomponent rehabilitation intervention in survivors of critical illness following discharge from the hospital after an intensive care unit (ICU) admission compared with standard care on health-related quality of life at 8 weeks. Design, Setting, and Participants: Pragmatic, multicenter, assessor-blinded, randomized clinical trial conducted from December 2022 to November 2025 at 52 National Health Service hospitals in the UK. Participants were adults who had been discharged from the hospital within the last 12 weeks with an ICU admission (required mechanical ventilation for ≥48 hours during ICU stay). Interventions: Individuals were randomized to a 6-week, remote, multicomponent, individualized, rehabilitation intervention incorporating weekly symptom management; targeted exercise; psychological support; and peer support and information commenced within 12 weeks of hospital discharge (n = 231) or standard care (n = 198). Main Outcomes and Measures: The primary outcome was health-related quality of life at 8 weeks measured by the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5L) utility score (from -0.285 [worst/worse than dead] to 1 [best health]; minimum clinically important difference: 0.08) and analyzed using linear regression (adjusted for baseline covariates). The secondary outcomes included leg strength and exercise capacity; self-reported perception of fatigue, anxiety, or depression; illness perception; acceptability of the intervention; and any adverse events. Results: Of the 3705 screened patients, 429 (12%) were randomized (mean age, 55.4 [SD, 13.9] years; 184 female [42.9%]; 245 male [57.1%]; and had median Acute Physiology and Chronic Health Evaluation II score of 18 [IQR, 14 to 22]). The mean EQ-5D-5L utility score at 8 weeks was 0.69 (SD, 0.26) in the intervention group compared with 0.67 (SD, 0.27) in the standard care group (adjusted mean difference, 0.04 [95% CI, -0.001 to 0.09]; P = .05). The intervention improved 4 of the 6 secondary outcomes, including leg strength and exercise capacity, fatigue, anxiety, and acceptability of the intervention; there was no change in perception of depression or illness. Four adverse events were related to the intervention; no serious events were attributed to the intervention. Conclusions and Relevance: A 6-week, multicomponent, rehabilitation program did not improve health-related quality of life at 8 weeks after discharge in ICU survivors who required mechanical ventilation. Trial Registration: isrctn.org Identifier: ISRCTN11266403.