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
  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

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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 July 28, 2014