DeliriumNCT05113446
MDD(Mild Cognitive Impairment Delirium Dementia) Cohort
An observational study of Delirium and Mild Cognitive Impairment, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
Trial summary
Identify the degree of delirium in subjects with mild cognitive impairment and find the risk factors of delirium. Mortality, hospital stay, and medical expenses are analyzed as clinical consequences related to delirium incidence. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Mild Cognitive Impairment, Dementia
- What is being tested?
- Delirium assessment using S-CAM
- How many people
- 163 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jul 2021to 31 Dec 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
- No healthy volunteers
- Older adult
Study population: Patients admitted to 3 long-term care (LTC) facilities
Who may be able to join
- Patients 65 years of age or older who are admitted to a LTC
- Patients diagnosed with mild cognitive impairment by doctors
- Patients with a score of 18 or more and 23 or less on the Mini-Mental State Examination
Who cannot join
- Patients unable to measure the delirium assessment tool, The Short Confusion Assessment Methods (S-CAM) (Inouye, 2014) due to severe vision and hearing problems
- Patients with serious psychiatric or neurological diagnosis,Patients who expire or were transferred on the day of admission -
- Patients receiving emergency treatment at the time of the delirium assessment or unable to measure or intervene with S-CAM due to hospital circumstances
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Yangsan Seoul long-term care (LTC) facilities
Daegu, Gyeongsangnam-do, 50572
YooJeong Yang, 821054258230, hp79797@naver.com
- Not yet recruiting
Gunsan Chamsarang long-term care (LTC) facilities
Daegu, Jeollabuk-do, 54078
Hyeonsuk An, +821020788428, rkdxogns76@naver.com
About this study
Official title: A Prospective, Longitudinal Cohort Study of the Incidence of Dementia After the Onset of Delirium in Patients With Mild Cognitive Impairment: MDD Cohort (Mild Cognitive Impairment Delirium Dementia)
- Identify the degree of delirium in subjects with mild cognitive impairment and find the risk factors of delirium. Mortality, hospital stay, and medical expenses are analyzed as clinical consequences related to delirium incidence.
- Dementia conversion rate and conversion period of subjects with mild cognitive impairment with delirium and it identifies the effect of delirium on dementia conversion.
- Develop an AI(Artificial intelligence) algorithm for predicting dementia transition in subjects with mild cognitive impairment based on the research results of the 1st, 2nd, and 3rd years.
- Conditions
- Delirium, Mild Cognitive Impairment, Dementia
- Being tested
- Delirium assessment using S-CAM
- Keywords
- delirium, mild cognitive impairment, dementia
- Medical subject headings
- Delirium, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium assessment using S-CAMDiagnostic test
Twice a day, the rounds of nurses in shifts, 8:00 am - 10:00 am, 4:00 pm - 6:00 pm Trained research assistants assessed delirium using S-CAM
| Study group | Role | What they receive |
|---|---|---|
| MCI(Mild Cognitive Impairment) group | * Inclusion criteria : Patients 65 years of age or older who are admitted to a LTC(long-term care) facilities, Patients diagnosed with mild cognitive impairment by doctors, Patients with a score of 18 or more and 23 or less on the Mini-Mental State Examination
* Exclusion criteria : Patients unable to measure the delirium assessment tool, The Short Confusion Assessment Methods (S-CAM) (Inouye, 2014) due to severe vision and hearing problems, Patients with serious psychiatric or neurological diagnosis,Patients who died or were transferred on the day of admission, Patients receiving emergency treatment at the time of the delirium assessment or unable to measure or intervene with S-CAM due to hospital circumstances Receives: Diagnostic Test: Delirium assessment using S-CAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence in participants with mild cognitive impairment
descriptive statistics
Measured: The number of subjects evaluated as positive in the delirium assessment using S-CAM for 30 days from the 1st day of study participation is statistically calculated.
Dementia conversion rate and transition period in participants with mild cognitive impairment
descriptive statistics
Measured: The participant's dementia conversion is checked in units of 1 month, and the period until conversion to dementia is analyzed in units of 12 months for 36 months.
Secondary outcomes (4)
Risk factors affecting participants' delirium
Logistic Regression
Measured: On the first day of data collection, the characteristics of subjects are collected through medical records. After 12 months, the risk factors affecting the occurrence of delirium among the characteristics of the subject are analyzed.
Mortality
Kaplan-Meier survival, Cox proportional hazard regression, Logistic Regression
Measured: It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.
hospital length of stay
Linear Regression
Measured: The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
healthcare costs
Linear Regression
Measured: From the healthcare costs consumed during the hospital length of stay, the direct healthcare costs used only for treatment are calculated in won units and analyzed in units of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jul 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 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 DeliriumStudies 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
- Prospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung ja Moon, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113446
- Sponsor's protocol ID
- 2019R1I1A3A0106056112
- Status last verified
- Jul 2022
- First submitted
- 17 Oct 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moon KJ, Park M. Protocol for a prospective, longitudinal cohort study on the incidence of dementia after the onset of delirium in patients with mild cognitive impairment: MDDCohort (Mild Cognitive Impairment Delirium Dementia). BMC Geriatr. 2024 Nov 7;24(1):922. doi: 10.1186/s12877-024-05480-6.
PubMed 39511473
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Cohort Study of the Incidence of Dementia After the Onset of Delirium in Patients With Mild Cognitive Impairment: MDD Cohort (Mild Cognitive Impairment Delirium Dementia)
- ClinicalTrials.gov ID
- NCT05113446
- Acronym / sponsor ID
- 2019R1I1A3A0106056112
- Conditions
- Delirium, Mild Cognitive Impairment, Dementia
- Keywords
- delirium, mild cognitive impairment, dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Nov 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.
- Identify the degree of delirium in subjects with mild cognitive impairment and find the risk factors of delirium. Mortality, hospital stay, and medical expenses are analyzed as clinical consequences related to delirium incidence.
- Dementia conversion rate and conversion period of subjects with mild cognitive impairment with delirium and it identifies the effect of delirium on dementia conversion.
- Develop an AI(Artificial intelligence) algorithm for predicting dementia transition in subjects with mild cognitive impairment based on the research results of the 1st, 2nd, and 3rd years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCI(Mild Cognitive Impairment) group | – | Diagnostic Test: Delirium assessment using S-CAM* Inclusion criteria : Patients 65 years of age or older who are admitted to a LTC(long-term care) facilities, Patients diagnosed with mild cognitive impairment by doctors, Patients with a score of 18 or more and 23 or less on the Mini-Mental State Examination * Exclusion criteria : Patients unable to measure the delirium assessment tool, The Short Confusion Assessment Methods (S-CAM) (Inouye, 2014) due to severe vision and hearing problems, Patients with serious psychiatric or neurological diagnosis,Patients who died or were transferred on the day of admission, Patients receiving emergency treatment at the time of the delirium assessment or unable to measure or intervene with S-CAM due to hospital circumstances |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to 3 long-term care (LTC) facilities
Key inclusion criteria (3 listed)
- Patients 65 years of age or older who are admitted to a LTC
- Patients diagnosed with mild cognitive impairment by doctors
- Patients with a score of 18 or more and 23 or less on the Mini-Mental State Examination
Key exclusion criteria (3 listed)
- Patients unable to measure the delirium assessment tool, The Short Confusion Assessment Methods (S-CAM) (Inouye, 2014) due to severe vision and hearing problems
- Patients with serious psychiatric or neurological diagnosis,Patients who expire or were transferred on the day of admission -
- Patients receiving emergency treatment at the time of the delirium assessment or unable to measure or intervene with S-CAM due to hospital circumstances
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 |
|---|---|---|
| Delirium assessment using S-CAMTwice a day, the rounds of nurses in shifts, 8:00 am - 10:00 am, 4:00 pm - 6:00 pm Trained research assistants assessed delirium using S-CAM | Diagnostic test | MCI(Mild Cognitive Impairment) group |
Primary outcome
Delirium incidence in participants with mild cognitive impairment
Time frame: The number of subjects evaluated as positive in the delirium assessment using S-CAM for 30 days from the 1st day of study participation is statistically calculated.
descriptive statistics
Dementia conversion rate and transition period in participants with mild cognitive impairment
Time frame: The participant's dementia conversion is checked in units of 1 month, and the period until conversion to dementia is analyzed in units of 12 months for 36 months.
descriptive statistics
4 secondary outcomes
Risk factors affecting participants' delirium
Time frame: On the first day of data collection, the characteristics of subjects are collected through medical records. After 12 months, the risk factors affecting the occurrence of delirium among the characteristics of the subject are analyzed.
Mortality
Time frame: It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.
hospital length of stay
Time frame: The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
healthcare costs
Time frame: From the healthcare costs consumed during the hospital length of stay, the direct healthcare costs used only for treatment are calculated in won units and analyzed in units of 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 39511473Moon KJ, Park M. Protocol for a prospective, longitudinal cohort study on the incidence of dementia after the onset of delirium in patients with mild cognitive impairment: MDDCohort (Mild Cognitive Impairment Delirium Dementia). BMC Geriatr. 2024 Nov 7;24(1):922. doi: 10.1186/s12877-024-05480-6.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Mild Cognitive Impairment, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
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 3 inclusion and 3 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 Kyoung ja Moon, doctor (+821023026302, kjmoon2150@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence in participants with mild cognitive impairment (time frame: The number of subjects evaluated as positive in the delirium assessment using S-CAM for 30 days from the 1st day of study participation is statistically calculated.). The study lists 2 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 NCT05113446, 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 1 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.