Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
IBS school
IBS-guidebook
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Patient education
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
Sites / Locations
- Dept of Internal Medicine, Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Structured patients group intervention - IBS school
Written information - IBS-guidebook
Outcomes
Primary Outcome Measures
Effect on GI symptoms as measured by IBS-SSS
Secondary Outcome Measures
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.
Full Information
NCT ID
NCT00706758
First Posted
June 25, 2008
Last Updated
July 19, 2011
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00706758
Brief Title
Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
Official Title
Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Perceived knowledge about IBS
IBS Severity Scoring System (IBS-SSS)
IBS Quality of Life (IBSQOL)
Visceral Sensitivity Index (VSI)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Patient education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Structured patients group intervention - IBS school
Arm Title
2
Arm Type
Active Comparator
Arm Description
Written information - IBS-guidebook
Intervention Type
Behavioral
Intervention Name(s)
IBS school
Intervention Description
Structured patient group education
Intervention Type
Behavioral
Intervention Name(s)
IBS-guidebook
Intervention Description
Written information - IBS-guidebook
Primary Outcome Measure Information:
Title
Effect on GI symptoms as measured by IBS-SSS
Time Frame
Basleline and 3 and 6 months
Secondary Outcome Measure Information:
Title
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.
Time Frame
Baseline, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Internal Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
We'll reach out to this number within 24 hrs