- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706758
Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome
Study Overview
Status
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gothenburg, Sweden, 41345
- Dept of Internal Medicine, Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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: 1
Structured patients group intervention - IBS school
|
Structured patient group education
|
Active Comparator: 2
Written information - IBS-guidebook
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Written information - IBS-guidebook
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect on GI symptoms as measured by IBS-SSS
Time Frame: Basleline and 3 and 6 months
|
Basleline and 3 and 6 months
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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: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Magnus Simrén, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S487-02
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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