Remote rehabilitation after intensive care
| ISRCTN | ISRCTN11266403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11266403 |
| IRAS number | 310777 |
| Secondary identifying numbers | IRAS 310777, NIHR HTA 132871, CPMS 53647 |
- Submission date
- 04/07/2022
- Registration date
- 26/07/2022
- Last edited
- 22/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Patients in intensive care units (ICU) need a great deal of special care and support as they are very ill. This can include time spent on a breathing machine. When patients leave hospital, their muscles are often still weak and their ability to do everyday things may still be affected. They also can feel very upset, with flashbacks to what happened, and confused memories of their time in the ICU. Patients need rehabilitation (support and exercises) when they are home but in most areas in the UK there is no organised rehabilitation for people after they get home. The aim of this study is to find out if a rehabilitation programme can help people after getting home from intensive care. This research will test a 6-week remote (online) rehabilitation programme.
Who can participate?
Patients who have gone home after critical illness and have been on a breathing machine in intensive care
What does the study involve?
Half of the participants will get standard NHS care and half will get the 6-week iRehab programme. The remote rehabilitation programme will be delivered by a trained healthcare team who understand the effects of critical illness. Patients have helped to identify what should be included so it is based on what patients’ needs are. The programme will be online, using written and computer-based information, exercise and strategies to promote recovery. If a person does not have a computer the researchers will provide a tablet (portable device) or send information by post. The healthcare team will speak to every patient taking part in the programme (online or by phone) on a weekly basis, to give guidance about how to manage symptoms. The researchers will ask everyone in the study about their quality of life, physical strength, and emotional wellbeing. They will also ask everyone about their tiredness, views about illness, and anxiety levels. This will be collected at 8 weeks and at 6 months by researchers. The researchers will also measure the value for money for the NHS.
Where is the study run from?
Warwick Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
January 2022 to January 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (UK)
Who is the main contact?
1. Dr Brenda O'Neill, b.oneill@ulster.ac.uk
2. Prof. Danny McAuley, d.f.mcauley@qub.ac.uk
3. Ms Kerry Raynes
4. Prof. Julie Bruce, irehab@warwick.ac.uk
Contact information
Principal Investigator
1F119 Shore Road
Jordanstown Campus
Newtownabbey
BT37 OQB
United Kingdom
 ORCID ID |
0000-0002-6471-1413 |
|---|---|
| Phone | +44 (0)2895 368812 |
| b.oneill@ulster.ac.uk |
Principal Investigator
Wellcome-Wolfson Institute for Experimental Medicine
Queen’s University
Belfast
BT9 7BL
United Kingdom
| ORCID ID |
0000-0002-3283-1947 |
|---|---|
| Phone | +44 (0)28 90635794 |
| d.f.mcauley@qub.ac.uk |
Study information
| Study design | Pragmatic randomized (allocation ratio 1: 1.17) controlled assessor-blind multi-centre trial with internal pilot and embedded process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact iRehab@warwick.ac.uk to request a participant information sheet |
| Scientific title | Remote multicomponent rehabilitation compared to standard care for survivors of critical illness after hospital discharge: a randomised controlled assessor-blind clinical and cost-effectiveness trial with an internal pilot (iRehab) |
| Study acronym | iRehab |
| Study hypothesis | Hypothesis: For people following a hospital admission that included ≥48 hours in an ICU for a critical illness, a 6-week remote multicomponent rehabilitation intervention improves health-related quality of life, physical function, fatigue, mood, and other health-related outcomes after 8 weeks, compared to best practice standard care. |
| Ethics approval(s) | Approved 18/05/2022, London - Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK;+44 (0)207 104 8225; londoncentral.rec@hra.nhs.uk), ref: 22/LO/0314 |
| Condition | Any condition requiring admission to intensive care and 48 hours of invasive mechanical ventilation |
| Intervention | Six-week remote multi-component, individualised, rehabilitation intervention incorporating: weekly symptom management; targeted exercise; psychological support; and peer support and information compared to standard care Half of the participants will be randomised to receive standard NHS care and half will receive the 6-week iRehab programme. The randomisation schedule with be generated using a computerised system. Randomisation will use a minimisation algorithm. The remote rehabilitation programme will be delivered by a trained healthcare team who understand the effects of critical illness. Patients have helped to identify what should be included so it is based on what patients’ needs are. The programme will be online, using written and computer-based information, exercise and strategies to promote recovery. If a person does not have a computer the researchers will provide a tablet (portable device) or send information by post. The healthcare team will speak to every patient taking part in the programme (online or by phone) on a weekly basis, to give guidance about how to manage symptoms. The researchers will ask everyone in the study about their quality of life, physical strength, and emotional wellbeing. They will also ask everyone about their tiredness, views about illness, and anxiety levels. This will be collected at 8 weeks and at 6 months by researchers. The researchers will also measure value for money for the NHS. |
| Intervention type | Mixed |
| Primary outcome measure | Health-related quality of life (HRQoL) measured using EQ-5D-5L at 8 weeks |
| Secondary outcome measures | 1. Physical function measured using 30-sec Sit-To-Stand at 8 weeks and 6 months 2. Illness perceptions measured using Brief Illness Perceptions Questionnaire at 8 weeks and 6 months 3. Fatigue measured using Functional Assessment of Chronic Illness therapy at 8 weeks and 6 months 4. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) at 8 weeks and 6 months 5. Health and social care use measured using the healthcare and social care utilisation questionnaire at 8 weeks and 6 months 6. Safety measured using data on serious adverse events collected at 8 weeks and 6 months Added 10/10/2023: 7. Intervention acceptability measured using a Theoretical Framework Acceptability Questionnaire (TFAQ) at 8 weeks |
| Overall study start date | 01/01/2022 |
| Overall study end date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 428 |
| Total final enrolment | 429 |
| Participant inclusion criteria | Adults within 12 weeks of hospital discharge after treatment of a critical illness requiring ICU care and mechanical ventilation for ≥48 hours |
| Participant exclusion criteria | 1. Declined consent or unable to provide consent 2. Previous randomisation into the present trial 3. Participating in another rehabilitation or self-management support trial 4. Contra-indication to exercise 5. Severe mental health problems that preclude participation in a group intervention 6. Discharged to a rehabilitation unit, or care home with/without nursing care 7. Prisoners |
| Recruitment start date | 18/11/2022 |
| Recruitment end date | 18/04/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Aylesbury
HP21 8AL
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Woolwich
London
SE18 4QH
United Kingdom
Fazakerley
Liverpool
L9 7AL
United Kingdom
Liverpool
L7 8XP
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Oldham
OL1 2JH
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Barnstaple
EX31 4JB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Craigavon
BT63 5QQ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Hereford
HR1 2BN
United Kingdom
Southampton
SO16 6YD
United Kingdom
Carmarthen
SA31 2AF
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Watford
WD18 0HB
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
Croydon
CR9 2PQ
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Pontyclun
CF72 8XR
United Kingdom
Sutton Coldfield
B75 7RR
United Kingdom
Bordesley Green
Birmingham
B9 5SS
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Bury Saint Edmunds
IP33 2QZ
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
London
N19 5NF
United Kingdom
London
NW3 2QG
United Kingdom
Ilford
IG3 8YB
United Kingdom
Warrington Road
Prescot
L35 5DR
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Hensingham
Whitehaven
CA28 8JG
United Kingdom
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Grainger Drive
Apley
Telford
TF1 6TF
United Kingdom
Brighton
BN2 5BE
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Rotherham
S60 2UD
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Plaistow
London
E13 8SL
United Kingdom
London
E11 1NR
United Kingdom
Sponsor information
University/education
Shore Road
Newtownabbey
BT37 OQB
Northern Ireland
United Kingdom
| Phone | +44 (0)2895365123 |
|---|---|
| N.Curry@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/ |
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Brenda O’Neill (b.oneill@ulster.ac.uk). Type of data: Individual participant data collected during the trial, after deidentification. When the data will become available and for how long: 3 months following publication of the study manuscripts. By what access criteria data will be shared including with whom: Requests for data sharing will be reviewed on an individual basis by the chief investigators. What types of analyses: All purposes/research questions will be considered on a case-by-case basis. What mechanism: Data requests should be directed to b.oneill@ulster.ac.uk. To gain access, data requestors will need to sign a data access agreement. Data sharing will be undertaken in accordance with the required regulatory requirements. Consent from participants: Participants consent to information being collected potentially being used to support future research, and being shared anonymously with other researchers. Any proposed research should have ethics approval where necessary. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
22/04/2025: The following changes were made to the study record:
1. Whipps Cross Hospital was added to the study participating centres.
2. The recruitment end date was changed from 30/05/2025 to 18/04/2025.
3. Total final enrolment added.
04/04/2025: The recruitment end date was changed from 30/04/2025 to 30/05/2025.
08/01/2025: Doncaster Royal Infirmary, Princess Royal Hospital, Royal Sussex County Hospital, Northern General Hospital, Rotherham Hospital, Sunderland Hospital and Newham University Hospital were added as study participating centres.
08/11/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2024 to 30/04/2025.
2. The overall study end date was changed from 31/12/2024 to 31/01/2026.
3. The intention to publish date was changed from 01/06/2025 to 28/02/2026.
05/06/2024: Whiston Hospital, Royal Berkshire Hospital, James Cook Hospital, Cumberland Infirmary, West Cumberland Hospital and Great Western Hospital added to the study participating centres.
07/03/2024: The recruitment end date was changed from 31/03/2024 to 30/06/2024.
08/01/2024: The study participating centres were updated to remove Fairfield General Hospital and add Southampton General Hospital, Glangwili General Hospital, Derriford Hospital, Manchester Royal Infirmary, Watford General Hospital, Wythenshawe Hospital, North Manchester General Hospital, Queen's Hospital, Royal Blackburn Hospital, Royal Glamorgan/Prince Charles Hospital, Good Hope Hospital, Birmingham Heartlands Hospital, Glan Clwyd Hospital, Ysbyty Gwynedd, Bangor, Wrexham Maelor Hospital, West Suffolk Hospital, Kingston Hospital, Warrington Hospital, Whittington Hospital, Royal Free Hospital and King George Hospital.
04/01/2024: The recruitment end date was changed from 31/01/2024 to 31/03/2024.
10/10/2023: The secondary outcome measures were updated.
20/09/2023: A link to the HRA research summary was added.
18/11/2022: The recruitment start date has been changed from 01/11/2022 to 18/11/2022.
25/10/2022: The recruitment start date has been changed from 01/10/2022 to 01/11/2022.
10/08/2022: The recruitment start date has been changed from 15/08/2022 to 01/10/2022.
04/08/2022: Internal review.
14/07/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.
