Contact information
Type
Scientific
Primary contact
Dr Anne Kennedy
ORCID ID
Contact details
National Primary Care Centre
5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
akennedy@fs1.cpcr.man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC11162
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
To evaluate attendant changes in a range of other health outcomes, including use of
secondary care, self-care, general health and quality of life.
Overall trial start date
01/06/2000
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant 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
Recruitment start date
01/06/2000
Recruitment end date
31/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Primary Care Centre
Manchester
M13 9PL
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
Funders
Funder type
Government
Funder name
National Health Service (NHS) 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
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17018196
Publication citations
-
Results
Richardson G, Sculpher M, Kennedy A, Nelson E, Reeves D, Roberts C, Robinson A, Rogers A, Thompson D, Is self-care a cost-effective use of resources? Evidence from a randomized trial in inflammatory bowel disease., J Health Serv Res Policy, 2006, 11, 4, 225-230, doi: 10.1258/135581906778476508.