Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

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 description: 
      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)

      The interventions:

      The education is designed based on the self-efficacy theory , and the general theory of
      nursing. Moreover, the education is performed based on a biopsychosocial model considered to
      be important in functional GI disorders. The multidisciplinary education consists of six
      sessions held once per week in a group setting with eight to ten patients in each group. Five
      different health care professionals (nurse, gastroenterologist, dietician, physiotherapist
      and psychologist) are involved in the education, in order to cover a wide spectra of issues
      related to IBS. Each of the professionals will hold one session for two hours where a lot of
      space is given for discussion in the group. This intervention has been described in detail
      previously (Ringström et. al. BMC Gastroenterol 2009;9:10).

      The nurse based education consists of three sessions held ones per week in a group setting
      with eight to ten patients in each group. A nurse, special trained in gastroenterology, is
      involved in this education, which covers the same spectra of issues related ti IBS as the
      multidisciplinary version.
    

Intervention name(s): Patient education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Patient education