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

August 9, 2011 updated by: Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, S413-45
        • Dept of Internal Medicine, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multidisciplinary patient education
A multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
Behavioral: Patient education
Active Comparator: Nurse based patient education
A nurse based patient education with three sessions for patients with IBS.
Behavioral: Patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Change from Baseline in GI Symptom severity and satisfactory relief of IBS symptoms at 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Change from Baseline in quality of life, psychological symptoms and knowledge at 3, 6 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Magnus Simrén, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-487-02 amendment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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