Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 6:00 AM
Study NCT ID:
NCT06470308
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067490', 'term': 'Prescription Drug Overuse'}, {'id': 'D000073496', 'term': 'Frailty'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090143', 'term': 'Medication Review'}, {'id': 'D000069340', 'term': 'Deprescriptions'}], 'ancestors': [{'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potentially Inappropriate Medication', 'timeFrame': '1 years', 'description': 'Determine if there is reduction in potentially Inappropriate medication after a deprescribing education intervention'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': '1 year', 'description': 'Evaluate if there is change in Health-Related Quality of Life using a validated questionnaire'}, {'measure': 'Medication adherence', 'timeFrame': '1 year', 'description': 'Evaluate if there is change in medication adherence using a validated questionnaire'}, {'measure': 'Frailty Status', 'timeFrame': '1 year', 'description': 'evaluation of frailty using a validated score'}, {'measure': 'Number of falls', 'timeFrame': '1 year', 'description': 'evaluation of self-reported falls'}, {'measure': 'Depression', 'timeFrame': '1 year', 'description': 'evaluation of geriatric depression using a validated questionnaire'}, {'measure': 'Fear of falling', 'timeFrame': '1 year', 'description': 'Evaluate if there is change in fear of falling using a validated questionnaire'}, {'measure': 'Emergency department visits and hospitalisations', 'timeFrame': '1 year', 'description': 'Evaluation of the number of emergency department visits and hospitalisations (self reported)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medication Overuse', 'Deprescriptions', 'Polypharmacy', 'Frailty Syndrome']}, 'descriptionModule': {'briefSummary': 'Polypharmacy is a major and growing public health problem occuring within all health care settings worldwide. The systematic review of Mansoon et al,2017 identified 138 different definitions for polypharmacy from which the most commonly used numerical definition is being this of five or more medicines. However, numerical definitions do not take into account factors such as comorbidity thus there is a need for a a shift towards the terms "appropriate" ,and "inappropriate polypharmacy" and potentially inappropriate prescribing (PIP). The prevalence of polypharmacy varies between 10% to as high as around 90% depending on the definition used and the population that is studied.There is worldwide literature regarding the epidemiology of polypharmacy in the elderly , health outcomes and cost. The is an abundance of guidelines and tools regarding deprescribing, the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing polypharmacy , minimizing inappropriate medication and improving outcomes. In Greece , as pointed out by the SIMPATHY project, there is no formal polypharmacy initiative and relative greek literature is scarce.There is no research in Greece regarding the prevalence of PIP among community-dwelling elderly patients as well as there are no studies evaluating the feasibility or effectiveness of deprescribing interventions in the elderly or older patients with frailty.\n\nThe aim of this thesis is to record, in the primary care setting in Crete, the underlying barriers and enablers of deprescribing among health care professionals and also to evaluate ,the clinical outcomes of deprescribing interventions in primary care. Additionally, the beliefs and attitudes of the patients and/or their caregivers towards deprescribing will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* community-dwelling patients\n* Age ≥ 65 years\n* Receive at least 5 medication ( polypharmacy )\n\nExclusion Criteria:\n\n* hospitalized or patients living in nursing home\n* Incapable of giving written consent'}, 'identificationModule': {'nctId': 'NCT06470308', 'briefTitle': 'Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty', 'organization': {'class': 'OTHER', 'fullName': 'University of Crete'}, 'officialTitle': 'Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty', 'orgStudyIdInfo': {'id': '93/12.06.2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'An educational intervention and training in deprescribing algorithms and deprescribing tools ( Beers Criteria, STOPP/START) will be provided to the general practitioners caring for the patients selected in the intervention arm.', 'interventionNames': ['Other: Medication Reviews and Deprescribing']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'No educational intervention will be provided to the general practitioners of the selected patients.'}], 'interventions': [{'name': 'Medication Reviews and Deprescribing', 'type': 'OTHER', 'description': 'General Practitioners will be given training and education in deprescribing algorithms and the conduction of medication reviews with the use of validated deprescribing tools such as the Beers Criteria and STOPP/START criteria.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71303', 'city': 'Heraklion', 'state': 'Heraklion, Crete', 'country': 'Greece', 'facility': 'Primary Care Facilities', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Ioanna Tsiligianni, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor in General Practice and Public Health, Department of Social Medicine, University of Crete'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All the data that will be collected, will be retained only during the period needed for the aims of this research. Technical and organizational measures will be taken in order to minimize potential loss, destruction or corruption of the data.After the completion of the thesis , all the data will be destroyed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Crete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD , PhD Candidate', 'investigatorFullName': 'Alexandros Paraskevopoulos', 'investigatorAffiliation': 'University of Crete'}}}}