Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT03524560
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2018-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors for Polypharmacy in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily drug consumption', 'timeFrame': '1 day', 'description': 'Number of drugs used everyday'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['comprehensive geriatric assesment, polypharmacy,geriatric depression scale,neutrophil/lymphocyte ratio'], 'conditions': ['Polypharmacy']}, 'descriptionModule': {'briefSummary': "Patients who were 65 years old or older and applied to Melek Hatun family practice center were enrolled in the study. All patients were seen either in our center or in their homes, and informed consents were obtained. Comprehensive Geriatric Assessment (CGA) was performed for each subject. Data were evaluated by PASW 17. The amount of medicines that the patient used everyday (DDC) was dependent variable. Relationships between DDC and other continuous variables were examined by Pearson's correlation. For categorical independent variables, t-tests were performed.", 'detailedDescription': "1000 patients who were 65 years old or older and applied to Melek Hatun family practice center either in person or through a relative between 01 December 2014 and 01 August 2017 were enrolled in the study. All patients were seen either in our center or in their homes, and informed consents were obtained. Comprehensive Geriatric Assessment (CGA) consisting of detailed history and examination, drug consumption information, Body Mass Index (BMI), Waist Circumference (WC), Timed Up \\& Go test (TUG), Clock Drawing Test (CD), Activities of Daily Living and Instrumental Activities of Daily Living scales (ADL \\& IADL), Mini Mental State Examination (MMSE), Tinetti Gait and Tinetti Balance scores (TG \\&TB), 30 items Geriatric Depression Scale (GDS) was performed for each subject\\[8-16\\]. Additional tests like blood examinations or ECG were performed on the basis of necessity. Metabolic Syndrome (MS) was diagnosed according to WHO criteria \\[17\\].\n\nData were evaluated by PASW 17. The amount of medicines that the patient used everyday (Daily Drug Consumption-DDC) were dependent variable. Relationships between DDC and other continuous variables were examined by Pearson's correlation. For categorical independent variables, t-tests were performed. The variables which were found associated with DDC were controlled for confounding variables by linear regressions. To avoid collinearity problems, variables that were strongly interrelated (like CD and MMSE) were not added to the regression model together. For all analyses, the level of significance was assumed as 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All of the patients who were 65 years old or older and applied to Melek Hatun family practice center either in person or through a relative between 01 December 2014 and 01 August 2017 were enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of 65\n\nExclusion Criteria:\n\n* Patients under 65 years\n* Patients who do not want to participate in the study'}, 'identificationModule': {'nctId': 'NCT03524560', 'briefTitle': 'Risk Factors for Polypharmacy in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Risk Factors for Polypharmacy in Older Adults in a Primary Care Setting:A Cross Sectional Study', 'orgStudyIdInfo': {'id': 'KBU-BAP-33/1-KA-077'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comprehensive geriatric assesment', 'type': 'OTHER', 'description': 'Comprehensive Geriatric Assesment (CGA) consisting of detailed history and examination, drug consumption information, Body Mass Index (BMI), Waist Circumference (WC), Timed Up \\& Go test (TUG), Clock Drawing Test (CD), Activities of Daily Living and Instrumental Activities of Daily Living scales (ADL \\& IADL), Mini Mental State Examination (MMSE), Tinetti Gait and Tinetti Balance scores (TG \\&TB), 30 items Geriatric Depression Scale (GDS) was performed for each subject'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Selcuk Engin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melekhatun family practice center'}]}, 'ipdSharingStatementModule': {'url': 'https://goo.gl/wyq8QY', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the completion of the study data will be available', 'ipdSharing': 'YES', 'description': 'All collected IPD will be made available', 'accessCriteria': 'among the colleagues who kindly request the data set by sending email to any of the authors will be given the url to reach the related data content'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist.Prof. Department of Family Medicine', 'investigatorFullName': 'SULEYMAN ERSOY', 'investigatorAffiliation': 'Karabuk University'}}}}