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Evaluation of Patient Education in Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305968
First Posted: March 22, 2006
Last Update Posted: December 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sykehuset Telemark
The Hospital of Vestfold
Information provided by (Responsible Party):
Sorlandet Hospital HF
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Change in Quality of life [ Time Frame: 6 months ]
  • Change in Gastrointestinal symptom score [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Change in health related costs [ Time Frame: 6 months ]
  • Evaluation of further patient needs after education [ Time Frame: 6 months ]

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)
Intervention Details:
    Behavioral: patient education
    Patient education group
Detailed 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305968


Locations
Norway
Sorlandet Sykehus HF
Kristiansand, Norway, 4633
Sponsors and Collaborators
Sorlandet Hospital HF
Sykehuset Telemark
The Hospital of Vestfold
Investigators
Study Director: Jostein Sauar, PhD
  More Information

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00305968     History of Changes
Other Study ID Numbers: SSHFIBS-1
First Submitted: March 21, 2006
First Posted: March 22, 2006
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by Sorlandet Hospital HF:
Quality of life
Gastrointestinal symptoms
Health related costs

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases