Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients (EPIC)
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|ClinicalTrials.gov Identifier: NCT03370523|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment|
|Polypharmacy Drug-drug Interactions||Other: No intervention is planned in our study|
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.
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.
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.
EPIC will be the first study evaluating polypharmacy, potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
- Other: No intervention is planned in our study
No intervention is planned in our study
- Prevalence of polypharmacy [ Time Frame: 6 months ]Polypharmacy will be defined as being on five or more medications at one time.
- 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.
- 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.
- Prevalence of inappropriate medications [ Time Frame: 6 months ]Potentially inappropriate medications will be defined with 2015 update of Beers criteria.
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
|Nizip State Hospital||Recruiting|
|Contact: IBRAHIM HALIL OZDEMIR, M.D. +90 342 517 54 00 email@example.com|