Rehabilitation following critical illness
ISRCTN | ISRCTN38674852 |
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DOI | https://doi.org/10.1186/ISRCTN38674852 |
Secondary identifying numbers | RHC18082 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jane Eddleston
Scientific
Scientific
Central Manchester Healthcare NHS Trust
Critical Care Unit
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL.
United Kingdom
Phone | +44 (0)161 276 4551/2 |
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Jeddleston@fs3.cmht.nwest.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Rehabilitation following critical illness |
Study objectives | To test whether the provision of a self-help rehabilitation package to patients recovering from a critical illness will: help to alleviate the stress many patients feel during their convalescence; improve their physical and psychological recovery; reduce costs to the NHS in terms of fewer readmissions to hospital, reduction in GP visits and fewer specialist referrals |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Critical illness rehabilitation |
Intervention | 1. Self-help rehabilitation package 2. Standard post-ICU care |
Intervention type | Other |
Primary outcome measure | Added 12/01/10: 1. Levels of depression and anxiety (Hospital Anxiety and Depression Scale) 2. Phobic symptoms (Fear Index) 3. Posttraumatic stress disorder (PTSD)-related symptoms (Impact of Events Scale) 4. Scores on the Short-Form Health Survey physical dimension Measured at 8 wks and 6 months after intensive care unit (ICU) treatment 5. Memory for ICU was assessed at 2 wks post-ICU discharge using the ICU Memory Tool |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1998 |
Completion date | 01/01/2000 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 126 (added 12/01/10; see publication) |
Total final enrolment | 126 |
Key inclusion criteria | Patients in rehabilitation from intensive care units (ICUs) |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/01/1998 |
Date of final enrolment | 01/01/2000 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Central Manchester Healthcare NHS Trust
Manchester
M13 9WL.
United Kingdom
M13 9WL.
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | resuts | 01/10/2003 | Yes | No |
Editorial Notes
09/11/2022: Total final enrolment added.