Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 4:01 AM
Study NCT ID:
NCT01845168
Status:
UNKNOWN
Last Update Posted:
2013-10-29
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012307', 'term': 'Risk Factors'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert', 'timeFrame': 'one year'}, {'measure': 'Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine', 'timeFrame': 'one year'}, {'measure': 'Prescription changes: general changes in the frequency of NSAID ordinations', 'timeFrame': 'one year'}], 'primaryOutcomes': [{'measure': 'Patient outcome: The number of hospitalizations due to bleeding ulcer complication.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bleeding peptic ulcer', 'NSAID and Aspirin', 'Computer-alert', 'General practitioner'], 'conditions': ['Bleeding Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .\n\nOn the basis of "The Danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a "pop-up" window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.\n\nThe decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.', 'detailedDescription': 'The background of the study is that NSAIDs and Aspirins increase the risk of peptic ulcer bleeding. On average 1-2% of patients using NSAID and Aspirin will develope gastric ulcer bleeding. But for patients with one or more risk-factors, the risk increases to 9% per 6 months. The mortality in this case is 10-15%. Approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in Denmark.\n\nDanish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of NSAID or Aspirin.\n\nThe consumption of NSAID and Aspirin is large. A third of people over 60 are treated within a year with these preparations. The risk of developing gastric ulcer related to NSAID and Aspirin can be reduced by concomitant therapy with antacids. Several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01845168', 'briefTitle': 'Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using "Computer-alert" - a Randomized Study in General Practice', 'orgStudyIdInfo': {'id': 'S-20120034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Computer-alert', 'description': "2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors", 'interventionNames': ['Other: Computer-alert', 'Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors', 'Device: Computer-alert']}, {'type': 'NO_INTERVENTION', 'label': 'controlgroup, normal procedures', 'description': 'The control-group: GP working in normal procedures'}], 'interventions': [{'name': 'Computer-alert', 'type': 'OTHER', 'description': 'A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroids', 'armGroupLabels': ['Computer-alert']}, {'name': 'A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors', 'type': 'DEVICE', 'description': 'A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in combination, ADP-inhibitor, bloodthinning medicine, SSRI, and steroids', 'armGroupLabels': ['Computer-alert']}, {'name': 'Computer-alert', 'type': 'DEVICE', 'armGroupLabels': ['Computer-alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Funen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Johanna Petersen, MD', 'role': 'CONTACT', 'email': 'jmpetersen@health.sdu.dk', 'phone': '0045 24379220'}, {'name': 'Johanna Petersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Odense', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Johanna Petersen', 'role': 'CONTACT', 'email': 'jmpetersen@health.sdu.dk'}, {'name': 'Johanna Petersen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Johanna Petersen, MD', 'role': 'CONTACT', 'email': 'jmpetersen@health.sdu.dk'}, {'name': 'Jane Møller Hansen, MD, Ph.D', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Johanna Petersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.'}, {'name': 'Jane M Hansen, MD, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Afdeling for Medicinske mavetarmsygdomme'}, {'name': 'Johanna M Petersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Johanna Petersen', 'investigatorAffiliation': 'Odense University Hospital'}}}}