Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/11/2014
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 CKW Luces

ORCID ID

Contact details

AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
+44

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025172370

Study information

Scientific title

Acronym

Study hypothesis

This study is designed to determine whether there is a benefit in terms of satisfaction with care, disease-specific knowledge and QOL for inflammatory bowel disease patients who receive education about their illness by means of an information leaflet compared to those who do not.

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

Quality of life

Patient information sheet

Condition

Digestive System: Irritable Bowel Disease (IBD)

Intervention

The first phase of project is distribution of leaflets to 20 volunteer patients and nursing staff and doctors. Comments will be invited on the sheets and returned to investigators. Eligible patients will be identified from out-patients and invited to participate, and if they fill out a questionnaire will be later interviewed. Within 2 weeks of baseline assessment patients will be randomised into two groups with Crohn's Disease and Ulcerative Colitis. A further questionnaire will be sent via post at 3 and 12 months after recruitment followed by a further interview at 6-12 months at clinic appointment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

300 IBD patients

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300 IBD patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

AintreeTrust
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Aintree Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes