Structured Patient Education Versus Written Information 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) we plan
      to compare the effects of a structured patient group education (IBS school) with receiving
      only written information in the form of a IBS-guidebook. 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 and 6 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 structured patient group education (IBS school) with receiving
      only written information in the form of a IBS-guidebook. 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. A
      nurse, specialized in GI functional disorders will conduct an interview with each patient for
      about 30 minutes to collect additional information from the patients before inclusion. The
      patients will be informed about the positive results obtained in previous studies with both
      interventions, i.e. a structured patient education (IBS school) and a self-help guidebook.
      Patients with an organic GI disease and/or with another disease potentially affecting the GI
      symptoms were excluded. Likewise, patients with a severe psychiatric disease were 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 interviewed in a block during one week. After all these interviews 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 IBS school within two to
      three weeks, or to receive the IBS Guidebook. The patients in the guidebook group will be
      offered to participate in the IBS school six months later, as part of the clinical routine at
      our unit (as requested by the ethics committee). 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 and 6 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)

        5. The Hospital Anxiety and Depression Scale (HAD)

      The interventions:

      IBS school The IBS school 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 IBS-school 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. Submitted).

      IBS Guidebook The IBS Guidebook consists of two booklets, written for IBS patients by one of
      the gastroenterologists in this study (MS). The booklets are detailed and cover the same
      areas of issues related to IBS as are covered in the structured education, namely
      pathophysiological mechanisms, GI and extra intestinal symptoms, the diagnostic workup,
      treatment options, food related issues, psychological and lifestyle factors.
    

Intervention name(s): IBS school; IBS-guidebook
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Structured patient group education; Written information - IBS-guidebook
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Patient education