- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524560
Risk Factors for Polypharmacy in Older Adults
Risk Factors for Polypharmacy in Older Adults in a Primary Care Setting:A Cross Sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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].
Data 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients of 65
Exclusion Criteria:
- Patients under 65 years
- Patients who do not want to participate in the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily drug consumption
Time Frame: 1 day
|
Number of drugs used everyday
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selcuk Engin, Melekhatun family practice center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KBU-BAP-33/1-KA-077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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