Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome

NCT ID: NCT00706758

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Structured patients group intervention - IBS school

Group Type: ACTIVE_COMPARATOR

IBS school

Intervention Type: BEHAVIORAL

Structured patient group education

2

Written information - IBS-guidebook

Group Type: ACTIVE_COMPARATOR

IBS-guidebook

Intervention Type: BEHAVIORAL

Written information - IBS-guidebook

Interventions

IBS school

Structured patient group education

Intervention Type: BEHAVIORAL

IBS-guidebook

Written information - IBS-guidebook

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women 18 to 70 years old, with IBS according to the Rome II criteria
• Written informed consent

Exclusion Criteria

• An organic GI disease and/or with another disease potentially affecting the GI symptoms
• Severe psychiatric disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sahlgrenska University Hospital, Gothenburg, Sweden

Principal Investigators

Magnus Simrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

S487-02

Identifier Type: -

Identifier Source: org_study_id