Clinical Trial: Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome

Brief Summary: In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention.

Detailed Summary:

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. A nurse, specialized in GI functional disorders will conduct an interview with each patient for about 30 minutes to collect additional information from the patients before inclusion. The patients will be informed about the positive results obtained in previous studies with both interventions, i.e. a structured patient education (IBS school) and a self-help guidebook. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms were excluded. Likewise, patients with a severe psychiatric disease were excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be interviewed in a block during one week. After all these interviews the patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the IBS school within two to three weeks, or to receive the IBS Guidebook. The patients in the guidebook group will be offered to participate in the IBS school six months later, as part of the clinical routine at our unit (as requested by the ethics committee). The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline a
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Effect on GI symptoms as measured by IBS-SSS [ Time Frame: Basleline and 3 and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS. [ Time Frame: Baseline, 3 and 6 months ]

Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: June 25, 2008
Date Started: August 2004
Date Completion:
Last Updated: July 19, 2011
Last Verified: June 2008