Rehabilitation following critical illness

ISRCTN	ISRCTN38674852
DOI	https://doi.org/10.1186/ISRCTN38674852
Protocol serial number	RHC18082
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive North West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jane Eddleston
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
Email	Jeddleston@fs3.cmht.nwest.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2000

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	126
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

Central Manchester Healthcare NHS Trust

Manchester
M13 9WL.
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	resuts	01/10/2003		Yes	No

09/11/2022: Total final enrolment added.