PolypharmacyEPICNCT03370523
Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
An observational study of Polypharmacy and Drug-drug Interactions, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Drug-drug Interactions
- How many people
- 5,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2018to 30 Aug 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All consecutive patients older than 65 years who presented to cardiology outpatient clinics will be screened.
Who may be able to join
- All consecutive patients with aged ≥ 65 years
Who cannot join
- Patients under 65 years of age
- Patients who do not want to participate in our study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nizip State Hospital
Gaziantep
IBRAHIM HALIL OZDEMIR, M.D., +90 342 517 54 00, dribrahimhalilozdemir@gmail.com
About this 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. 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.
Read the 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.
- Conditions
- Polypharmacy, Drug-drug Interactions
- Being tested
- No intervention is planned in our study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned in our studyOther
No intervention is planned in our study
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of polypharmacy
Polypharmacy will be defined as being on five or more medications at one time.
Measured: 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.
Measured: 6 months
Drug-drug interactions
DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.
Measured: 6 months
Prevalence of inappropriate medications
Potentially inappropriate medications will be defined with 2015 update of Beers criteria.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start30 Jul 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA ÖZLEK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370523
- Sponsor's protocol ID
- MuglaSKUTRH
- Acronym
- EPIC
- Status last verified
- Jul 2019
- First submitted
- 1 Dec 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31311898
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
- ClinicalTrials.gov ID
- NCT03370523
- Acronym / sponsor ID
- EPIC / MuglaSKUTRH
- Conditions
- Polypharmacy, Drug-drug Interactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All consecutive patients older than 65 years who presented to cardiology outpatient clinics will be screened.
Key inclusion criteria (1 listed)
- All consecutive patients with aged ≥ 65 years
Key exclusion criteria (2 listed)
- Patients under 65 years of age
- Patients who do not want to participate in our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is planned in our studyNo intervention is planned in our study | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 31311898Ozlek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy and Drug-drug Interactions, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of polypharmacy (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.