Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome
A Comparison of a Short Nurse Based and a Long Multidisciplinary Version of Structured Patient Education in Irritable Bowel Syndrome.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedAugust 11, 2011
July 1, 2011
3.9 years
July 25, 2011
August 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect on GI symptoms as measured by IBS-SSS and satisfactory relief of IBS symptoms
Change from Baseline in GI Symptom severity and satisfactory relief of IBS symptoms at 3, 6 and 12 months.
Secondary Outcomes (1)
Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS
Change from Baseline in quality of life, psychological symptoms and knowledge at 3, 6 and 12 months.
Study Arms (2)
Multidisciplinary patient education
ACTIVE COMPARATORA multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
Nurse based patient education
ACTIVE COMPARATORA nurse based patient education with three sessions for patients with IBS.
Interventions
Eligibility Criteria
You may qualify if:
- Men and women 18 to 70 years old, with IBS according to the Rome II criteria.
- Written informed consent
You may not qualify if:
- An organic GI disease and/or with another disease potentially affecting the GI symptoms.
- Severe psychiatric disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, S413-45, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Simren, MD, PhD
Sahlgrenska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 27, 2011
Study Start
August 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 11, 2011
Record last verified: 2011-07