ISRCTN ISRCTN38674852
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRehabilitation following critical illness
Study objectivesTo 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) studiedCritical illness rehabilitation
Intervention1. Self-help rehabilitation package
2. Standard post-ICU care
Intervention typeOther
Primary outcome measureAdded 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 measuresNot provided at time of registration
Overall study start date01/01/1998
Completion date01/01/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants126 (added 12/01/10; see publication)
Total final enrolment126
Key inclusion criteriaPatients in rehabilitation from intensive care units (ICUs)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/1998
Date of final enrolment01/01/2000

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

Central Manchester Healthcare NHS Trust
Manchester
M13 9WL.
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.