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

NCT03370523 | Unknown

• 1 other identifier: MuglaSKUTRH
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Drug-drug Interactions

Outcome Measures

Primary Outcomes (4)

• Prevalence of polypharmacy

  Polypharmacy will be defined as being on five or more medications at one time.

  6 months

• Severity of comorbid diseases

  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.

  6 months

• Drug-drug interactions

  DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.

  6 months

• Prevalence of inappropriate medications

  Potentially inappropriate medications will be defined with 2015 update of Beers criteria.

  6 months

Interventions

No intervention is planned in our study OTHER

No intervention is planned in our study

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients older than 65 years who presented to cardiology outpatient clinics will be screened.

You may qualify if:

• All consecutive patients with aged ≥ 65 years

You may not qualify if:

• Patients under 65 years of age
• Patients who do not want to participate in our study

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Nizip State Hospital

Gaziantep, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Ozlek E, Cekic EG, Ozlek B, Cil C, Celik O, Dogan V, Basaran O, Tanik VO, Ozdemir HI, Celik Y, Kacmaz C, Simsek Z, Gunes HM, Safak O, Ozkan B, Tasar O, Onal C, Bekar L, Biteker M. Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Turk Kardiyol Dern Ars. 2019 Jul;47(5):391-398. doi: 10.5543/tkda.2019.27724.

  PMID: 31311898 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 12, 2017
• Study Start: July 30, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

TU (1)