Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT00305968
Status:
COMPLETED
Last Update Posted:
2011-12-21
First Post:
2006-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Patient Education in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-20', 'studyFirstSubmitDate': '2006-03-21', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': '6 months'}, {'measure': 'Change in Gastrointestinal symptom score', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in health related costs', 'timeFrame': '6 months'}, {'measure': 'Evaluation of further patient needs after education', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Quality of life', 'Gastrointestinal symptoms', 'Health related costs'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nElements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria\n* Must be able to participate in a education-group\n\nExclusion Criteria:\n\n* Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome\n* Serious, untreated psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT00305968', 'briefTitle': 'Evaluation of Patient Education in Irritable Bowel Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study', 'orgStudyIdInfo': {'id': 'SSHFIBS-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'patient education', 'type': 'BEHAVIORAL', 'description': 'Patient education group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4633', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sorlandet Sykehus HF', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Jostein Sauar, PhD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, {'name': 'The Hospital of Vestfold', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}