Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patient education
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
Multidisciplinary patient education
Nurse based patient education
Arm Description
A multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
A nurse based patient education with three sessions for patients with IBS.
Outcomes
Primary Outcome Measures
Effect on GI symptoms as measured by IBS-SSS and satisfactory relief of IBS symptoms
Secondary Outcome Measures
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS
Full Information
NCT ID
NCT01403493
First Posted
July 25, 2011
Last Updated
August 9, 2011
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01403493
Brief Title
Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome
Official Title
A Comparison of a Short Nurse Based and a Long Multidisciplinary Version of Structured Patient Education in Irritable Bowel Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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), 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:
Perceived knowledge about IBS
IBS Severity Scoring System (IBS-SSS)
IBS Quality of Life (IBSQOL)
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.
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
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary patient education
Arm Type
Active Comparator
Arm Description
A multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
Arm Title
Nurse based patient education
Arm Type
Active Comparator
Arm Description
A nurse based patient education with three sessions for patients with IBS.
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
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 Simren, 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
S413-45
Country
Sweden
12. IPD Sharing Statement
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Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome
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