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Evaluation of Patient Education in Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborators:
Sykehuset Telemark
The Hospital of Vestfold
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00305968
First received: March 21, 2006
Last updated: December 20, 2011
Last verified: December 2011
History of Changes

March 21, 2006
December 20, 2011
January 2006
January 2008   (final data collection date for primary outcome measure)
  • 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 Quality of life
  • Change in Gastrointestinal symptom score
Complete list of historical versions of study NCT00305968 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in health related costs
  • Evaluation of further patient needs after education
Not Provided
Not Provided
 
Evaluation of Patient Education in Irritable Bowel Syndrome
Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study

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.

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Irritable Bowel Syndrome
Behavioral: patient education
Patient education group
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00305968
SSHFIBS-1
Not Provided
Sorlandet Hospital HF
Sorlandet Hospital HF
  • Sykehuset Telemark
  • The Hospital of Vestfold
Study Director: Jostein Sauar, PhD
Sorlandet Hospital HF
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP