Evaluation of Patient Education in Irritable Bowel Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Behavioral: patient education |
Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 200 |
| 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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sorlandet Hospital HF |
| ClinicalTrials.gov Identifier: | NCT00305968 History of Changes |
| Other Study ID Numbers: | SSHFIBS-1 |
| Study First Received: | March 21, 2006 |
| Last Updated: | December 20, 2011 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by Sorlandet Hospital HF:
|
Quality of life Gastrointestinal symptoms Health related costs |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013