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 [version 1; peer review: 2 approved]
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 il...
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2025-04-01
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| author | Julie Bruce Jason Madan Martin Underwood Roger Kenyon Miriam Ratna Ranjit Lall Gavin D Perkins Ella Terblanche Kerry Raynes Brenda O'Neill Mandana Zanganeh Rowena Williams Danny McAuley Paul Dark Bronwen Connolly Chen Ji Judy Martina Bradley Rachel Clarke Jill Costley Nigel D Hart Penelope Firshman Katherine Jones Annette Henderson |
| author_facet | Julie Bruce Jason Madan Martin Underwood Roger Kenyon Miriam Ratna Ranjit Lall Gavin D Perkins Ella Terblanche Kerry Raynes Brenda O'Neill Mandana Zanganeh Rowena Williams Danny McAuley Paul Dark Bronwen Connolly Chen Ji Judy Martina Bradley Rachel Clarke Jill Costley Nigel D Hart Penelope Firshman Katherine Jones Annette Henderson |
| author_sort | Julie Bruce |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-5ea7dbd092994204b99ddda5b5ed2559 |
| institution | DOAJ |
| issn | 2633-4402 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | F1000 Research Ltd |
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| series | NIHR Open Research |
| spelling | doaj-art-5ea7dbd092994204b99ddda5b5ed25592025-08-20T03:22:19ZengF1000 Research LtdNIHR Open Research2633-44022025-04-01510.3310/nihropenres.13910.115118Remote 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 [version 1; peer review: 2 approved]Julie Bruce0https://orcid.org/0000-0002-8462-7999Jason Madan1Martin Underwood2Roger Kenyon3https://orcid.org/0009-0004-6112-4557Miriam Ratna4Ranjit Lall5Gavin D Perkins6Ella Terblanche7Kerry Raynes8Brenda O'Neill9https://orcid.org/0000-0002-6471-1413Mandana Zanganeh10https://orcid.org/0000-0003-3934-6044Rowena Williams11Danny McAuley12Paul Dark13Bronwen Connolly14https://orcid.org/0000-0002-5676-5497Chen Ji15Judy Martina Bradley16Rachel Clarke17Jill Costley18Nigel D Hart19Penelope Firshman20Katherine Jones21https://orcid.org/0000-0003-0615-8442Annette Henderson22University of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKPatient advisory group and PPI representative on iRehab Trial Management Group, Preston, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKPrincipal Critical Care Dietitian, Health Sciences University, Bournemouth, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUlster University Institute of Nursing and Health Research, Belfast, Northern Ireland, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKQueen's University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland, UKThe University of Manchester Division of Infection Immunity and Respiratory Medicine, Manchester, England, UKQueen's University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKQueen's University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland, UKUniversity Hospitals Plymouth NHS Trust, Plymouth, England, UKUlster University Institute of Nursing and Health Research, Belfast, Northern Ireland, UKGeneral Practitioner and Clinical Professor in General Practice, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland, UKSurrey and Sussex Healthcare NHS Trust, Redhill, England, UKUniversity of Warwick Warwick Clinical Trials Unit, Coventry, England, UKUlster University Institute of Nursing and Health Research, Belfast, Northern Ireland, UKBackground 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/ISRCTN11266403https://openresearch.nihr.ac.uk/articles/5-29/v1Intensive Care ICU Rehabilitation Recovery Critical illness Individualisedeng |
| spellingShingle | Julie Bruce Jason Madan Martin Underwood Roger Kenyon Miriam Ratna Ranjit Lall Gavin D Perkins Ella Terblanche Kerry Raynes Brenda O'Neill Mandana Zanganeh Rowena Williams Danny McAuley Paul Dark Bronwen Connolly Chen Ji Judy Martina Bradley Rachel Clarke Jill Costley Nigel D Hart Penelope Firshman Katherine Jones Annette Henderson 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 [version 1; peer review: 2 approved] NIHR Open Research Intensive Care ICU Rehabilitation Recovery Critical illness Individualised eng |
| 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 [version 1; peer review: 2 approved] |
| title_full | 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 [version 1; peer review: 2 approved] |
| title_fullStr | 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 [version 1; peer review: 2 approved] |
| title_full_unstemmed | 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 [version 1; peer review: 2 approved] |
| title_short | 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 [version 1; peer review: 2 approved] |
| title_sort | 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 version 1 peer review 2 approved |
| topic | Intensive Care ICU Rehabilitation Recovery Critical illness Individualised eng |
| url | https://openresearch.nihr.ac.uk/articles/5-29/v1 |
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