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Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01403493
First received: July 25, 2011
Last updated: August 9, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Patient education

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: A Comparison of a Short Nurse Based and a Long Multidisciplinary Version of Structured Patient Education in 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 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. ] [ 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: Change from Baseline in quality of life, psychological symptoms and knowledge at 3, 6 and 12 months. ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multidisciplinary patient education
A multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
Behavioral: Patient education
Active Comparator: Nurse based patient education
A nurse based patient education with three sessions for patients with IBS.
Behavioral: Patient education

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:

  1. Perceived knowledge about IBS
  2. IBS Severity Scoring System (IBS-SSS)
  3. IBS Quality of Life (IBSQOL)
  4. 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.

  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: NCT01403493

Locations
Sweden
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, S413-45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Magnus Simren, MD, PhD Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Magnus Simren, Sahlgrenska University Hospital, Gothenburg, Sweden
ClinicalTrials.gov Identifier: NCT01403493     History of Changes
Other Study ID Numbers: S-487-02 amendment
Study First Received: July 25, 2011
Last Updated: August 9, 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:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014