MDD(Mild Cognitive Impairment Delirium Dementia) Cohort

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05113446

Collaborator

(none)

163

Enrollment

Locations

Anticipated Duration (Months)

81.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Mild Cognitive Impairment Dementia	Diagnostic Test: Delirium assessment using S-CAM

Study Design

Study Type:

Observational

Anticipated Enrollment :

163 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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	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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Delirium incidence in participants with mild cognitive impairment [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 [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

Secondary Outcome Measures

Risk factors affecting participants' delirium [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.]
Logistic Regression
Mortality [It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.]
Kaplan-Meier survival, Cox proportional hazard regression, Logistic Regression
hospital length of stay [The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.]
Linear Regression
healthcare costs [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.]
Linear Regression

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yangsan Seoul long-term care (LTC) facilities	Daegu	Gyeongsangnam-do,	Korea, Republic of	50572
2	Gunsan Chamsarang long-term care (LTC) facilities	Daegu	Jeollabuk-do	Korea, Republic of	54078