Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04692220
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2020-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Related Problems : Focus on Age and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems', 'timeFrame': '1 day', 'description': 'Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems'}], 'secondaryOutcomes': [{'measure': 'Number and type of Adverse Drug Events and Drug-Related Problems', 'timeFrame': '1 day', 'description': 'Number and type of Adverse Drug Events and Drug-Related Problems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Related Problems', 'Clinical Pharmacist', 'Elderly', 'Diabetes'], 'conditions': ['Adverse Drug Events']}, 'descriptionModule': {'briefSummary': 'Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs.\n\nDRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including\n\n* medication reconciliation,\n* an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients.\n\nIn this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP.\n\nTranslated with www.DeepL.com/Translator (free version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population was composed of patient admitted in emergency department or medical units of Montpellier University hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Patients aged above 18 years old, admitted to the emergency department or hospital\n\nExclusion criteria:\n\n* Patients presenting acute psychological disturbance\n* Patients that did not agree to participate'}, 'identificationModule': {'nctId': 'NCT04692220', 'acronym': 'DRP-AD', 'briefTitle': 'Drug-Related Problems : Focus on Age and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes', 'orgStudyIdInfo': {'id': 'RECHMPL20_0667'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an Adverse Drug Events or Drug-Related Problems', 'description': 'Patients with an Adverse Drug Events or Drug-Related Problems', 'interventionNames': ['Other: Detection of Adverse Drug Events or Drug-Related Problems']}, {'label': 'Patients without an Adverse Drug Events or Drug-Related Problems', 'description': 'Patients without an Adverse Drug Events or Drug-Related Problems', 'interventionNames': ['Other: Detection of Adverse Drug Events or Drug-Related Problems']}], 'interventions': [{'name': 'Detection of Adverse Drug Events or Drug-Related Problems', 'type': 'OTHER', 'description': 'Detection of Adverse Drug Events or Drug-Related Problems', 'armGroupLabels': ['Patients with an Adverse Drug Events or Drug-Related Problems', 'Patients without an Adverse Drug Events or Drug-Related Problems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Cyril BREUKER, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}