Delirium in Old AgeNCT04973709
Prevalence of Dementia and Delirium in Outpatient Clinics (DESTAN Trial)
An observational study of Delirium in Old Age and Delirium Superimposed on Dementia, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to assess the prevalence and etiologic risk factors of delirium in outpatient geriatric patients and also hospitalized patients. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium in Old Age, Delirium Superimposed on Dementia, Delirium With Dementia
- What is being tested?
- Confussion assessment method (CAM) and Dementia diagnosis
- How many people
- 714 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2021to 11 Nov 2025
- 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
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older adults (65 years and older)
Who may be able to join
- We included all 65 years older patients who evaluated according to a comprehensive geriatric assessment that is consistently performed during admission to the outpatients' clinic of the hospital.
Who cannot join
- Exclusion criteria were serious psychiatric disorders such as schizophrenia or major depression.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane training and research hospital
Ankara, 06670
Bilal Katipoglu, MD, +905543330380, drbilal07@gmail.com
Mehmet I Naharcı, Prof
About this study
Official title: Gulhane Training and Research Hospital
The aim of this study is to assess the prevalence and etiologic risk factors of delirium in outpatient geriatric patients and also hospitalized patients.
Read the detailed description
This study aimed to investigate the frequency of delirium and examines the association between delirium and other possible risk factors and prognostic factors (dementia etc.)
- Being tested
- Confussion assessment method (CAM), Dementia diagnosis
- Keywords
- Delirium, Dementia, Mortality, Etiology, Outpatient
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confussion assessment method (CAM)Diagnostic test
Participants enrolled in the Delirium group according to the CAM.
Dementia diagnosisDiagnostic test
Participants enrolled in the Dementia group according to the CDR scores and MMSE scores and DSM4/5 criteria
| Study group | Role | What they receive |
|---|---|---|
| Delirium with dementia | Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. Receives: Diagnostic Test: Confussion assessment method (CAM); Diagnostic Test: Dementia diagnosis | |
| Dementia without Delirium | Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. Receives: Diagnostic Test: Dementia diagnosis | |
| Delirium without Dementia | Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. Receives: Diagnostic Test: Confussion assessment method (CAM) | |
| No dementia, No delirium | Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of Mortality
1st year mortality according to the electronic national data base
Measured: 1 year fellow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start5 Aug 2021
- Primary completion5 Oct 2022
- Study completion11 Nov 2025 (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 Delirium in Old AgeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
- Investigators
- Mehmet Naharcı, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973709
- Sponsor's protocol ID
- 2020-382
- Status last verified
- Oct 2022
- First submitted
- 4 Jul 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Katipoglu B, Demircan SK, Naharci MI. Association of drug burden index with delirium in community-dwelling older adults with dementia: a longitudinal observational study. Int J Clin Pharm. 2023 Oct;45(5):1267-1276. doi: 10.1007/s11096-023-01551-7. Epub 2023 Mar 18.
PubMed 36933080
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gulhane Training and Research Hospital
- ClinicalTrials.gov ID
- NCT04973709
- Acronym / sponsor ID
- 2020-382
- Keywords
- Delirium, Dementia, Mortality, Etiology, Outpatient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 22 Jul 2021 (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.
The aim of this study is to assess the prevalence and etiologic risk factors of delirium in outpatient geriatric patients and also hospitalized patients.
Detailed description
This study aimed to investigate the frequency of delirium and examines the association between delirium and other possible risk factors and prognostic factors (dementia etc.)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Delirium with dementia | – | Diagnostic Test: Confussion assessment method (CAM), Diagnostic Test: Dementia diagnosisDelirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. |
| Dementia without Delirium | – | Diagnostic Test: Dementia diagnosisDelirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. |
| Delirium without Dementia | – | Diagnostic Test: Confussion assessment method (CAM)Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. |
| No dementia, No delirium | – | –Delirium was detected using the short form of the Confusion Assessment Method (CAM) both at admission and daily throughout the hospital stay. Cognitive status was determined using the Mini-Mental State Exam, Clinical Dementia Rating (CDR). Dementia was defined by a CDR score of 1. The primary independent variable was a composite of delirium and dementia diagnosis, and we examined the overlap by categorizing the cases into four groups: no delirium or dementia, dementia alone, delirium alone, and DSD. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults (65 years and older)
Key inclusion criteria (1 listed)
- We included all 65 years older patients who evaluated according to a comprehensive geriatric assessment that is consistently performed during admission to the outpatients' clinic of the hospital.
Key exclusion criteria (1 listed)
- Exclusion criteria were serious psychiatric disorders such as schizophrenia or major depression.
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 |
|---|---|---|
| Confussion assessment method (CAM)Participants enrolled in the Delirium group according to the CAM. | Diagnostic test | Delirium with dementia, Delirium without Dementia |
| Dementia diagnosisParticipants enrolled in the Dementia group according to the CDR scores and MMSE scores and DSM4/5 criteria | Diagnostic test | Delirium with dementia, Dementia without Delirium |
Primary outcome
frequency of Mortality
Time frame: 1 year fellow-up
1st year mortality according to the electronic national data base
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 36933080Katipoglu B, Demircan SK, Naharci MI. Association of drug burden index with delirium in community-dwelling older adults with dementia: a longitudinal observational study. Int J Clin Pharm. 2023 Oct;45(5):1267-1276. doi: 10.1007/s11096-023-01551-7. Epub 2023 Mar 18.
- Individual participant dataSharing planned: No
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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.
Mehmet Naharcı principal investigator
Saglik Bilimleri Universitesi
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 Delirium in Old Age and Delirium Superimposed on Dementia, run by Gulhane Training and Research Hospital 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 1 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 25 Oct 2022. 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?
Contact Bilal Katipoglu, MD (+905543330380, drbilal07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of Mortality (time frame: 1 year fellow-up). 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 NCT04973709, 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 25 Oct 2022.