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

NCT ID: NCT01403493

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-07-31

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 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.

Conditions

Irritable Bowel Syndrome

Study Design

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

Study Groups

Multidisciplinary patient education

A multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.

Group Type: ACTIVE_COMPARATOR

Patient education

Intervention Type: BEHAVIORAL

Nurse based patient education

A nurse based patient education with three sessions for patients with IBS.

Group Type: ACTIVE_COMPARATOR

Patient education

Intervention Type: BEHAVIORAL

Interventions

Patient education

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 Simren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

S-487-02 amendment

Identifier Type: -

Identifier Source: org_study_id