Evaluation of Patient Education in Irritable Bowel Syndrome

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00305968
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.

Detailed Description

The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.

Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.

The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
• Must be able to participate in a education-group

Exclusion Criteria

• Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
• Serious, untreated psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Gastrointestinal symptom score	6 months
Change in Quality of life	6 months

Secondary Outcome Measures

Name	Time	Method
Change in health related costs	6 months
Evaluation of further patient needs after education	6 months

Trial Locations

Locations (1)

Sorlandet Sykehus HF; 🇳🇴 Kristiansand, Norway