Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients (EPIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370523
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
EDA ÖZLEK, Muğla Sıtkı Koçman University

Brief Summary:
As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. This study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in in elderly patients presenting to a outpatient cardiology clinics.

Condition or disease Intervention/treatment
Polypharmacy Drug-drug Interactions Other: No intervention is planned in our study

Detailed Description:

Objective:

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. However, very limited epidemiologic data are available describing polypharmacy, potentially DDIs, and potentially inappropriate medications and their consequences in elderly Turkish patients. Therefore, this study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics.

Methods:

The EPIC (Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be the first large-scale, observational, real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey. We will enroll all consecutive patients (aged≥ 65 years) admitted to the outpatient cardiology clinics from January 30, 2018, through June 30, 2018, provided written informed consent. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

Results:

Patient demographics, disease characteristics, laboratory test results and medications used willl be collected by self reports and medical records. The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. Polypharmacy will be defined as being on five or more medications at one time, DDIs will be checked with Lexicomp® and and potentially inappropriate medications will be defined with 2015 update of Beers criteria. Severe drug interactions will be defined with category D or X DIs.

Conclusion:

EPIC will be the first study evaluating polypharmacy, potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions


Intervention Details:
  • Other: No intervention is planned in our study
    No intervention is planned in our study


Primary Outcome Measures :
  1. Prevalence of polypharmacy [ Time Frame: 6 months ]
    Polypharmacy will be defined as being on five or more medications at one time.

  2. Severity of comorbid diseases [ Time Frame: 6 months ]
    The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.

  3. Drug-drug interactions [ Time Frame: 6 months ]
    DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.

  4. Prevalence of inappropriate medications [ Time Frame: 6 months ]
    Potentially inappropriate medications will be defined with 2015 update of Beers criteria.



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.


Layout table for eligibility information
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 consecutive patients older than 65 years who presented to cardiology outpatient clinics will be screened.
Criteria

Inclusion Criteria:

  • All consecutive patients with aged ≥ 65 years

Exclusion Criteria:

  • Patients under 65 years of age
  • Patients who do not want to participate in our 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): NCT03370523


Locations
Layout table for location information
Turkey
Nizip State Hospital Recruiting
Gaziantep, Turkey
Contact: IBRAHIM HALIL OZDEMIR, M.D.    +90 342 517 54 00    dribrahimhalilozdemir@gmail.com   
Sponsors and Collaborators
Muğla Sıtkı Koçman University
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: EDA ÖZLEK, Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier: NCT03370523    
Other Study ID Numbers: MuglaSKUTRH
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No