MDD(Mild Cognitive Impairment Delirium Dementia) Cohort

Dementia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113446
• Other study ID #: 2019R1I1A3A0106056112
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: Keimyung University Dongsan Medical Center
• Contact: Kyoung ja Moon, doctor
• Phone: +821023026302
• Email: kjmoon2150[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. - 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

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 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Dementia
• Mild Cognitive Impairment

Intervention

Diagnostic Test:
• Delirium assessment using S-CAM
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

Locations

Country	Name	City	State
Korea, Republic of	Gunsan Chamsarang long-term care (LTC) facilities	Daegu	Jeollabuk-do
Korea, Republic of	Yangsan Seoul long-term care (LTC) facilities	Daegu	Gyeongsangnam-do,

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium incidence in participants with mild cognitive impairment	descriptive statistics	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.
Primary	Dementia conversion rate and transition period in participants with mild cognitive impairment	descriptive statistics	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	Risk factors affecting participants' delirium	Logistic Regression	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.
Secondary	Mortality	Kaplan-Meier survival, Cox proportional hazard regression, Logistic Regression	It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.
Secondary	hospital length of stay	Linear Regression	The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
Secondary	healthcare costs	Linear Regression	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.