Evaluation of Patient Education in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305968
• Other study ID #: SSHFIBS-1
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: December 20, 2011
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2011
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• patient education
Patient education group

Locations

Country	Name	City	State
Norway	Sorlandet Sykehus HF	Kristiansand

Sponsors (3)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Sykehuset Telemark, The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of life		6 months	No
Primary	Change in Gastrointestinal symptom score		6 months	No
Secondary	Change in health related costs		6 months	No
Secondary	Evaluation of further patient needs after education		6 months	No