NCT00305968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

March 21, 2006

Last Update Submit

December 20, 2011

Conditions

Irritable Bowel Syndrome

Keywords

Quality of lifeGastrointestinal symptomsHealth related costs

Outcome Measures

Primary Outcomes (2)

  • Change in Quality of life

    6 months

  • Change in Gastrointestinal symptom score

    6 months

Secondary Outcomes (2)

  • Change in health related costs

    6 months

  • Evaluation of further patient needs after education

    6 months

Interventions

patient educationBEHAVIORAL

Patient education group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Sykehus HF

Kristiansand, 4633, Norway

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jostein Sauar, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations

NO(1)