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Trial record 2 of 20 for:    polypharmacy in general practice

Risk Factors for Polypharmacy in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524560
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
SULEYMAN ERSOY, Karabuk University

Brief Summary:
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.

Condition or disease Intervention/treatment
Polypharmacy Other: Comprehensive geriatric assesment

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Years
Official Title: Risk Factors for Polypharmacy in Older Adults in a Primary Care Setting:A Cross Sectional Study
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : December 1, 2017

Intervention Details:
  • Other: Comprehensive geriatric assesment
    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


Primary Outcome Measures :
  1. Daily drug consumption [ Time Frame: 1 day ]
    Number of drugs used everyday



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients of 65

Exclusion Criteria:

  • Patients under 65 years
  • Patients who do not want to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524560


Sponsors and Collaborators
Karabuk University
Investigators
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Principal Investigator: Selcuk Engin Melekhatun family practice center

Additional Information:

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Responsible Party: SULEYMAN ERSOY, Assist.Prof. Department of Family Medicine, Karabuk University
ClinicalTrials.gov Identifier: NCT03524560    
Other Study ID Numbers: KBU-BAP-33/1-KA-077
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After the completion of the study data will be available
Access Criteria: 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
URL: https://goo.gl/wyq8QY

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SULEYMAN ERSOY, Karabuk University:
comprehensive geriatric assesment, polypharmacy,geriatric depression scale,neutrophil/lymphocyte ratio