Clinical Trial: Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Comparison of a Short Nurse Based and a Long Multidisciplinary Version of Structured Patient Education in Irritable Bowel Syndrome.

Brief Summary: In this randomized controlled study in patients with irritable bowel syndrome (IBS), the investigators plan to compare the effects of a multidisciplinary structured patient group education with a compressed nurse based structured patient group education. The effects of the interventions on gastrointestinal (GI) and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12 months after the intervention.

Detailed Summary:

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a multidisciplinary, structured patient group education with a compressed, nurse based, structured patient group education. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. The patients will be informed about the positive results obtained in previous studies with different educational interventions. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms are excluded. Likewise, patients with a severe psychiatric disease are excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be included in a block. The patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the multidisciplinary or the nurse based education within two to three weeks. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12 months after the intervention:

  1. Perceived knowledge about IBS
  2. IBS Severity Scoring System (IBS-SSS)
  3. IBS Quality of Life (IBSQOL)
  4. Visceral Sensitivity Index (VSI)

4. The Hospital Anxiety and Depression Scale (HAD) Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Effect on GI symptoms as measured by IBS-SSS and satisfactory relief of IBS symptoms [ Time Frame: Change from Baseline in GI Symptom severity and satisfactory relief of IBS symptoms at 3, 6 and 12 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS [ Time Frame: Change from Baseline in quality of life, psychological symptoms and knowledge at 3, 6 and 12 months. ]

Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: July 25, 2011
Date Started: August 2007
Date Completion:
Last Updated: August 9, 2011
Last Verified: July 2011