A randomised controlled trial (RCT) of a Patient Self-Help Information Book in the Management of Irritable Bowel Syndrome (IBS)

ISRCTN	ISRCTN03226666
DOI	https://doi.org/10.1186/ISRCTN03226666
Protocol serial number	RHC11162
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	National Health Service (NHS) UK

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Anne Kennedy
Scientific

National Primary Care Centre
5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Email	akennedy@fs1.cpcr.man.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Use of a self-help guidebook will reduce or modify doctor-patient contacts and improve the health status and symptoms of patients with IBS. Patients randomised to the self-help group will gain additional benefits resulting in better symptom control, reduced anxiety and fewer doctor contacts.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Irritable bowel syndrome
Intervention	1. Provision of self-help guidebook 2. Provision of self-help guidebook plus invitation to attend one self-help group meeting 3. Treatment as usual, plus guidebook at the end of the study
Intervention type	Other
Primary outcome measure(s)	To test the impact of two self-help interventions (a comprehensive self-help guidebook and a self-help group) on primary care consultation rates and global IBS symptom severity in patients with functional bowel disease
Key secondary outcome measure(s)	To evaluate attendant changes in a range of other health outcomes, including use of secondary care, self-care, general health and quality of life.
Completion date	31/05/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	420
Key inclusion criteria	1. A working diagnosis of IBS as the reason for the consultation 2. At least one other visit with IBS symptoms in the preceding year 3. IBS diagnosed by GP (or hospital if patient has been seen by specialist) but not necessarily fulfilling 'Rome' criteria 4. Able to read and understand English
Key exclusion criteria	1. Patients under the age of 18 2. Patients with significant learning difficulty or dementia who, in the opinion of the GP, would be unable to practice self-care
Date of first enrolment	01/06/2000
Date of final enrolment	31/05/2003

National Primary Care Centre

Manchester
M13 9PL
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No