Evaluation of Patient Education in Irritable Bowel Syndrome

Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00305968

Enrollment

200

Registered

2006-03-22

Start date

2006-01-31

Completion date

2008-01-31

Last updated

2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Quality of life, Gastrointestinal symptoms, Health related costs

Brief summary

About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.

Detailed description

The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital. Elements in this school-day includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices. The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).

Interventions

BEHAVIORALpatient education

Patient education group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria * Must be able to participate in a education-group

Exclusion criteria

* Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome * Serious, untreated psychiatric disorder

Design outcomes

Primary

Measure	Time frame
Change in Quality of life	6 months
Change in Gastrointestinal symptom score	6 months

Secondary

Measure	Time frame
Change in health related costs	6 months
Evaluation of further patient needs after education	6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026