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

B O'Neill; Judy M Bradley; Bronwen Connolly; Julie Bruce; Martin Underwood; Ranjit Lall; Chen Ji; Jill Costley; Rachel Clarke; Paul Dark; Penelope Firshman; Nigel D Hart; Annette Henderson; Katherine Jones; Roger Kenyon; Jason  Madan; Gavin D Perkins; Mariam Ratna; Kerry Raynes; Ella Terblanche; Rowena Williams; Mandana Zanganeh; Danny McAuley

doi:10.3310/nihropenres.13910.1

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

B O'Neill
, Judy M Bradley
, Bronwen Connolly
, Julie Bruce
, Martin Underwood
, Ranjit Lall
, Chen Ji
, Jill Costley
, Rachel Clarke
, Paul Dark
, Penelope Firshman
, Nigel D Hart
, Annette Henderson
, Katherine Jones
, Roger Kenyon
, Jason Madan
, Gavin D Perkins
, Mariam Ratna
, Kerry Raynes
, Ella Terblanche

Rowena Williams, Mandana Zanganeh, Danny McAuley

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

18 Downloads (Pure)

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

Original language	English
Article number	29
Number of pages	22
Journal	NIHR open research
Volume	5
Issue number	29
Early online date	11 Apr 2025
DOIs	https://doi.org/10.3310/nihropenres.13910.1
Publication status	Published online - 11 Apr 2025

Bibliographical note

Publisher Copyright:
Copyright: © 2025 O'Neill B et al.

Data Availability Statement

No data available at this protocol stage

Funding

This project is funded by the National Institute for Health Research (NIHR) under its [National Institute for Health and Care Research Health Technology Assessment (HTA) Programme\u2019 (Grant Reference Number:132871)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Funder number
132871

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being
SDG 10 Reduced Inequalities

Keywords

Intensive Care, ICU, Rehabilitation, Recovery, Critical illness, Individualised, Remote
Critical illness
Individualised
Remote
ICU
Rehabilitation
Intensive Care
Recovery

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Extended Data Files: 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.
O'Neill, B., Bradley, J. M. (Contributor), Connolly, B. (Contributor), Bruce, J. (Contributor), Underwood, M. (Contributor), Lall, R. (Contributor), Ji, C. (Contributor), Costley, J. (Contributor), Clarke, R. (Contributor), Dark, P. (Contributor), Firshman, P. (Contributor), Hart, N. D. (Contributor), Henderson, A. (Contributor), Jones, K. (Contributor), Kenyon, R. (Contributor), Madan, J. (Contributor), Perkins, G. D. (Contributor), Ratna, M. (Contributor), Raynes, K. (Contributor) & Terblanche, E. (Contributor) & 3 others, Williams, R. (Contributor), Zanganeh, M. (Contributor) & McAuley, D. (Contributor), 6 Feb 2025, (Unpublished) Ulster University.
Research output: Other contribution › Protocol

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Cite this

O'Neill, B., Bradley, J. M., Connolly, B., Bruce, J., Underwood, M., Lall, R., Ji, C., Costley, J., Clarke, R., Dark, P., Firshman, P., Hart, N. D., Henderson, A., Jones, K., Kenyon, R., Madan, J., Perkins, G. D., Ratna, M., Raynes, K., ... McAuley, D. (2025). 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. NIHR open research, 5(29), Article 29. Advance online publication. https://doi.org/10.3310/nihropenres.13910.1

@article{c7757bb044f34d819c311e7018f5f772,

title = "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",

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author = "B O'Neill and Bradley, \{Judy M\} and Bronwen Connolly and Julie Bruce and Martin Underwood and Ranjit Lall and Chen Ji and Jill Costley and Rachel Clarke and Paul Dark and Penelope Firshman and Hart, \{Nigel D\} and Annette Henderson and Katherine Jones and Roger Kenyon and Jason Madan and Perkins, \{Gavin D\} and Mariam Ratna and Kerry Raynes and Ella Terblanche and Rowena Williams and Mandana Zanganeh and Danny McAuley",

note = "Publisher Copyright: Copyright: {\textcopyright} 2025 O'Neill B et al.",

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doi = "10.3310/nihropenres.13910.1",

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O'Neill, B, Bradley, JM, Connolly, B, Bruce, J, Underwood, M, Lall, R, Ji, C, Costley, J, Clarke, R, Dark, P, Firshman, P, Hart, ND, Henderson, A, Jones, K, Kenyon, R, Madan, J, Perkins, GD, Ratna, M, Raynes, K, Terblanche, E, Williams, R, Zanganeh, M & McAuley, D 2025, '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', NIHR open research, vol. 5, no. 29, 29. https://doi.org/10.3310/nihropenres.13910.1

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. / O'Neill, B; Bradley, Judy M; Connolly, Bronwen et al.
In: NIHR open research, Vol. 5, No. 29, 29, 11.04.2025.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Remote multicomponent rehabilitation compared to standard care for survivors of critical illness after hospital discharge (iRehab)

T2 - a protocol for a randomised controlled assessor-blind clinical and cost-effectiveness trial

AU - O'Neill, B

AU - Bradley, Judy M

AU - Connolly, Bronwen

AU - Bruce, Julie

AU - Underwood, Martin

AU - Lall, Ranjit

AU - Ji, Chen

AU - Costley, Jill

AU - Clarke, Rachel

AU - Dark, Paul

AU - Firshman, Penelope

AU - Hart, Nigel D

AU - Henderson, Annette

AU - Jones, Katherine

AU - Kenyon, Roger

AU - Madan, Jason

AU - Perkins, Gavin D

AU - Ratna, Mariam

AU - Raynes, Kerry

AU - Terblanche, Ella

AU - Williams, Rowena

AU - Zanganeh, Mandana

AU - McAuley, Danny

PY - 2025/4/11

Y1 - 2025/4/11

N2 - 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

AB - 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

KW - Intensive Care, ICU, Rehabilitation, Recovery, Critical illness, Individualised, Remote

KW - Critical illness

KW - Individualised

KW - Remote

KW - ICU

KW - Rehabilitation

KW - Intensive Care

KW - Recovery

UR - https://www.scopus.com/pages/publications/105006976429

UR - https://pure.ulster.ac.uk/en/publications/c7757bb0-44f3-4d81-9c31-1e7018f5f772

U2 - 10.3310/nihropenres.13910.1

DO - 10.3310/nihropenres.13910.1

M3 - Article

C2 - 40443419

SN - 2633-4402

VL - 5

JO - NIHR open research

JF - NIHR open research

IS - 29

M1 - 29

ER -

O'Neill B, Bradley JM, Connolly B, Bruce J, Underwood M, Lall R et al. 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. NIHR open research. 2025 Apr 11;5(29):29. Epub 2025 Apr 11. doi: 10.3310/nihropenres.13910.1

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

Bibliographical note

Data Availability Statement

Funding

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Research output

Extended Data Files: 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.

Cite this