Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/09/2012
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 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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes