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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00706758
First received: June 25, 2008
Last updated: July 19, 2011
Last verified: June 2008
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: IBS school
Behavioral: IBS-guidebook

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Effect on GI symptoms as measured by IBS-SSS [ Time Frame: Basleline and 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS. [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: August 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Structured patients group intervention - IBS school
Behavioral: IBS school
Structured patient group education
Active Comparator: 2
Written information - IBS-guidebook
Behavioral: IBS-guidebook
Written information - IBS-guidebook

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706758

Locations
Sweden
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Magnus Simrén, MD, PhD Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Magnus Simrén, Sahlgrenska University Hospital, Gothenburg, Sweden
ClinicalTrials.gov Identifier: NCT00706758     History of Changes
Other Study ID Numbers: S487-02
Study First Received: June 25, 2008
Last Updated: July 19, 2011
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Sahlgrenska University Hospital, Sweden:
Irritable bowel syndrome
Patient education

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014