Evaluation of Patient Education in Irritable Bowel Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study|
- Change in Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in Gastrointestinal symptom score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in health related costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Evaluation of further patient needs after education [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Behavioral: patient education
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305968
|Sorlandet Sykehus HF|
|Kristiansand, Norway, 4633|
|Study Director:||Jostein Sauar, PhD|