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NCT Number: NCT00305968

Evaluation of Patient Education in Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sorlandet Sykehus HF

Kristiansand, 4633, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education

Behavioral

Patient education group

Primary outcomes

  1. Change in Quality of life

    Time frame: 6 months

  2. Change in Gastrointestinal symptom score

    Time frame: 6 months

Secondary outcomes

  1. Change in health related costs

    Time frame: 6 months

  2. Evaluation of further patient needs after education

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Sykehuset Telemark
  • The Hospital of Vestfold

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2006
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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