NCT04973709

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2025

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

July 4, 2021

Last Update Submit

October 23, 2022

Conditions

Keywords

DeliriumDementiaMortalityEtiologyOutpatient

Outcome Measures

Primary Outcomes (1)

  • frequency of Mortality

    1st year mortality according to the electronic national data base

    1 year fellow-up

Study Arms (4)

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.

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.

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.

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.

Interventions

Participants enrolled in the Delirium group according to the CAM.

Delirium with dementiaDelirium without Dementia
Dementia diagnosisDIAGNOSTIC_TEST

Participants enrolled in the Dementia group according to the CDR scores and MMSE scores and DSM4/5 criteria

Delirium with dementiaDementia without Delirium

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling older adults (65 years and older)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane training and research hospital

Ankara, 06670, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DeliriumDementia

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Mehmet Naharcı

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilal Katipoglu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 22, 2021

Study Start

August 5, 2021

Primary Completion

October 5, 2022

Study Completion

November 11, 2025

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations