Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Eddleston

ORCID ID

Contact details

Central Manchester Healthcare NHS Trust
Critical Care Unit
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL.
United Kingdom
+44 (0)161 276 4551/2
Jeddleston@fs3.cmht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC18082

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Critical illness rehabilitation

Intervention

1. Self-help rehabilitation package
2. Standard post-ICU care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/1998

Overall trial end date

01/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Patients in rehabilitation from intensive care units (ICUs)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

126 (added 12/01/10; see publication)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/1998

Recruitment end date

01/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 resuts in http://www.ncbi.nlm.nih.gov/pubmed/14530751

Publication citations

  1. Resuts

    Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M, Rehabilitation after critical illness: a randomized, controlled trial., Crit. Care Med., 2003, 31, 10, 2456-2461, doi: 10.1097/01.CCM.0000089938.56725.33.

Additional files

Editorial Notes