Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-16 @ 5:30 PM
Study NCT ID:
NCT03840018
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Postal Intervention to Improve the Use of PPI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-10-06', 'releaseDate': '2020-09-15'}], 'estimatedResultsFirstSubmitDate': '2020-09-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active prescriptions of each proton pump inhibitors dose after the intervention', 'timeFrame': '6 months', 'description': 'Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Overdose']}, 'descriptionModule': {'briefSummary': 'It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.', 'detailedDescription': 'The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).\n\nThe main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.\n\nExclusion Criteria:\n\n* Patients whose GPs declined to participate'}, 'identificationModule': {'nctId': 'NCT03840018', 'briefTitle': 'Effectiveness of a Postal Intervention to Improve the Use of PPI', 'organization': {'class': 'OTHER', 'fullName': 'Osakidetza'}, 'officialTitle': 'Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors', 'orgStudyIdInfo': {'id': 'EVB-IBP-2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed'}, {'type': 'OTHER', 'label': 'Letter by post to patients', 'description': 'Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor', 'interventionNames': ['Other: Letter by post to patients']}], 'interventions': [{'name': 'Letter by post to patients', 'type': 'OTHER', 'description': 'Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review', 'armGroupLabels': ['Letter by post to patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20270', 'city': 'Hondarribia', 'state': 'Gipuzkoa', 'country': 'Spain', 'facility': 'Bidasoa Integrated Health Organization', 'geoPoint': {'lat': 43.36859, 'lon': -1.79622}}], 'overallOfficials': [{'name': 'Elena Valverde', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osakidetza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osakidetza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary care pharmacist', 'investigatorFullName': 'Elena Valverde', 'investigatorAffiliation': 'Osakidetza'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-15', 'type': 'RELEASE'}, {'date': '2020-10-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Elena Valverde, Primary care pharmacist, Osakidetza'}}}}