Evaluation of Patient Education in Irritable Bowel Syndrome
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.
|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|