PolypharmacyNCT03524560
Risk Factors for Polypharmacy in Older Adults
An observational study of Polypharmacy, run by Karabuk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Comprehensive geriatric assesment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 1 Dec 2017
- How long will I take part?
- 3 Years
- 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 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.
Who may be able to join
- Patients of 65
Who cannot join
- Patients under 65 years
- Patients who do not want to participate in the study
About this study
Official title: Risk Factors for Polypharmacy in Older Adults in a Primary Care Setting:A Cross Sectional Study
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.
Read the 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.
- Conditions
- Polypharmacy
- Being tested
- Comprehensive geriatric assesment
- Keywords
- comprehensive geriatric assesment, polypharmacy,geriatric depression scale,neutrophil/lymphocyte ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive geriatric assesmentOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily drug consumption
Number of drugs used everyday
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Dec 2014
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULEYMAN ERSOY, Karabuk University
- Investigators
- Selcuk Engin, Principal investigator, Melekhatun family practice center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524560
- Sponsor's protocol ID
- KBU-BAP-33/1-KA-077
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be made available
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Polypharmacy in Older Adults in a Primary Care Setting:A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03524560
- Acronym / sponsor ID
- KBU-BAP-33/1-KA-077
- Conditions
- Polypharmacy
- Keywords
- comprehensive geriatric assesment, polypharmacy,geriatric depression scale,neutrophil/lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 May 2018 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients of 65
Key exclusion criteria (2 listed)
- Patients under 65 years
- Patients who do not want to participate in the 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 |
|---|---|---|
| Comprehensive geriatric assesmentComprehensive 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 | Other | – |
Primary outcome
Daily drug consumption
Time frame: 1 day
Number of drugs used everyday
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: Yes. All collected IPD will be made available
Related trials for Polypharmacy
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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.
Selcuk Engin principal investigator
Melekhatun family practice center
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy, run by Karabuk University.
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: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily drug consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2018.