Patient Education for Patients With Irritable Bowel Syndrome (IBS)

NCT03466281 | Completed

• 1 other identifier: IBS patient education
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled study in patients with irritable bowel syndrome (IBS) the investigators plan to compare the effects of a structured patient group education (IBS School) with structured education provided via the internet. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline, immediately after the intervention and 3 and 6 months after the intervention.

Conditions

Patient Education; IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change of GI symptoms

  Measured with a questionnaire; Irritable Bowel Syndrome-severity scoring system (IBS-SSS). Five issues measure the severity of IBS symptoms on a scale, each ranging from 0 to 100. A total score is calculated ranging from 0 to 500. In this study the total score is used, the higher the score the worse severity of symptoms.

  Measuring change from Baseline and up to six months after the education

Secondary Outcomes (4)

• Change of Quality of life

  Measuring change from Baseline and up to six months after the education

• Change of Psychological symptoms

  Measuring change from Baseline and up to six months after the education

• Change of GI specific anxiety

  Measuring change from Baseline and up to six months after the education

• Change of Perceived knowledge about IBS

  Measuring change from Baseline and up to six months after the education

Study Arms (2)

IBS School

ACTIVE COMPARATOR

Patient education provided in a group setting

Behavioral: Structured patient group education

Internet patient education

ACTIVE COMPARATOR

Patient education provided via the internet

Behavioral: Education via Internet

Interventions

Structured patient group education BEHAVIORAL

Patient education in a group setting

IBS School

Education via Internet BEHAVIORAL

Patient education via the internet

Internet patient education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS according to the Rome III criteria

You may not qualify if:

• organic GI disease and/or another disease potentially affecting the GI symptoms
• severe psychiatric disease due to potential problems to participate in a group intervention
• disability to communicate in the Swedish language
• disability to use a computer or not have access to a computer or internet

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, S413-45, Sweden

Location

Related Publications (4)

• Ringstrom G, Storsrud S, Lundqvist S, Westman B, Simren M. Development of an educational intervention for patients with Irritable Bowel Syndrome (IBS): a pilot study. BMC Gastroenterol. 2009 Feb 4;9:10. doi: 10.1186/1471-230X-9-10.

  PMID: 19192312 RESULT

• Ringstrom G, Storsrud S, Posserud I, Lundqvist S, Westman B, Simren M. Structured patient education is superior to written information in the management of patients with irritable bowel syndrome: a randomized controlled study. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):420-8. doi: 10.1097/MEG.0b013e3283333b61.

  PMID: 19923998 RESULT

• Ringstrom G, Storsrud S, Simren M. A comparison of a short nurse-based and a long multidisciplinary version of structured patient education in irritable bowel syndrome. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):950-7. doi: 10.1097/MEG.0b013e328354f41f.

  PMID: 22617366 RESULT

• Lindfors P, Axelsson E, Engstrand K, Storsrud S, Jerlstad P, Tornblom H, Ljotsson B, Simren M, Ringstrom G. Online Education Is Non-Inferior to Group Education for Irritable Bowel Syndrome: A Randomized Trial and Patient Preference Trial. Clin Gastroenterol Hepatol. 2021 Apr;19(4):743-751.e1. doi: 10.1016/j.cgh.2020.04.005. Epub 2020 Apr 11.

  PMID: 32289541 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Magnus Simren, MD, Prof

  Dept of internal medicine, Gothenburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Active Comparator: 1 Structured patients group intervention - IBS School Active Comparator: 2 Structured Patient education via Internet

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: March 15, 2018
• Study Start: August 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: November 20, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)