Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT00618150
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2008-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Education in Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2008-02-05', 'studyFirstSubmitQcDate': '2008-02-05', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Dyspepsia', 'Education', 'Information'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '17998836', 'type': 'RESULT', 'citation': 'Urnes J, Farup PG, Lydersen S, Petersen H. Patient education in gastro-oesophageal reflux disease: a randomized controlled trial. Eur J Gastroenterol Hepatol. 2007 Dec;19(12):1104-10. doi: 10.1097/MEG.0b013e3282f163dc.'}, {'pmid': '19014552', 'type': 'DERIVED', 'citation': 'Urnes J, Petersen H, Farup PG. Disease knowledge after an educational program in patients with GERD--a randomized controlled trial. BMC Health Serv Res. 2008 Nov 13;8:236. doi: 10.1186/1472-6963-8-236.'}]}, 'descriptionModule': {'briefSummary': 'Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heartburn and acid regurgitation the dominant symptom\n* needing relief at least 5 days/ week when symptoms were at their worst\n* disease history at least 3 months\n* ability to give informed consent\n\nExclusion Criteria:\n\n* current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc\n* continuous need of proton pump inhibitors or NSAIDs\n* wish for surgical treatment\n* earlier surgical treatment in the GI-tract\n* pregnancy\n* alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT00618150', 'briefTitle': 'Patient Education in Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Patient Education in Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'Sak 33-96 (REK)'}, 'secondaryIdInfos': [{'id': 'SLKNR 96/00515'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Behavioral: Patient education']}], 'interventions': [{'name': 'Patient education', 'type': 'BEHAVIORAL', 'description': 'An educational program: Three lessons spaced over 2 weeks.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-7489', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology, Med. fac.', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Jorgen A Urnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Foundation for Health and Rehabilitation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jorgen Urnes/ principal researcher', 'oldOrganization': 'Norwegian University of Science and Technology'}}}}