Randomised controlled trial: impact of a patient information leaflet on satisfaction with care, knowledge and QOL in irritable bowel disease

ISRCTN	ISRCTN55878813
DOI	https://doi.org/10.1186/ISRCTN55878813
Protocol serial number	N0025172370
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Aintree Hospitals NHS Trust (UK), NHS R&D Support Funding (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr CKW Luces
Scientific

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

Phone	+44

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	300
Key inclusion criteria	300 IBD patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2007

AintreeTrust

Liverpool
L9 7AL
United Kingdom

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