Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 9:25 AM
Study NCT ID:
NCT05721534
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2023-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deprescribing and Health-related Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090143', 'term': 'Medication Review'}], 'ancestors': [{'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-reported health status', 'timeFrame': '4 months', 'description': '(on a scale from 1 to 10)'}], 'secondaryOutcomes': [{'measure': 'general condition', 'timeFrame': '4 months', 'description': '(rated on a 5-point Likert Scale)'}, {'measure': 'functional level', 'timeFrame': '4 months', 'description': 'rated on a 5-point Likert Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary care', 'Medication review', 'Deprescribing', 'Polypharmacy', 'Chronic disease management'], 'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': 'In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.', 'detailedDescription': "The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included care home residents living in selected care homes, in which the GPF was associated "care home doctors", and community-dwelling patients with chronic disease listed with the GPF.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.\n* patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.\n\nExclusion Criteria:\n\n* unable to collaborate on follow-up questionnaires'}, 'identificationModule': {'nctId': 'NCT05721534', 'briefTitle': 'Deprescribing and Health-related Effects', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Effective Deprescribing in Primary Care Without Deterioration of Health-related Outcomes', 'orgStudyIdInfo': {'id': 'K2023-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Care home residents', 'description': 'The intervention was offered to new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.', 'interventionNames': ['Other: Medication review']}, {'label': 'Community-dwelling patients with chronic disease', 'description': 'Patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.', 'interventionNames': ['Other: Medication review']}], 'interventions': [{'name': 'Medication review', 'type': 'OTHER', 'otherNames': ['Medication review with focus on deprescribing'], 'description': 'Annual consultation focusing on pharmacological treatment. This specific consultation constituted the "intervention". It included a structured review of the patient\'s health state, in addition to a structured medication review with a focus on appropriate medication and deprescribing.', 'armGroupLabels': ['Care home residents', 'Community-dwelling patients with chronic disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Anne E Olesen', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Estrup Olesen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Frederikshavn Kommune, Frederikshavn, Denmark', 'class': 'UNKNOWN'}, {'name': 'Lægeklinikken Frederikshavn, Frederikshavn, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anne Estrup Olesen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}