MDD(Mild Cognitive Impairment Delirium Dementia) Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Diagnostic test: Delirium assessment using S-CAM

• Study Type: Observational
• Enrollment (Anticipated): 163

Contacts and Locations

• Study Contact: Name: Kyoung ja Moon, doctor; Phone Number: +821023026302; Email: kjmoon2150@gmail.com
• Study Contact Backup: Name: min a Park; Phone Number: +821023026302; Email: kjmoon2150@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do,
    • Daegu, Gyeongsangnam-do,, Korea, Republic of, 50572
      • Recruiting
      • Yangsan Seoul long-term care (LTC) facilities
      • Contact: YooJeong Yang; Phone Number: 821054258230; Email: hp79797@naver.com
  • Jeollabuk-do
    • Daegu, Jeollabuk-do, Korea, Republic of, 54078
      • Not yet recruiting
      • Gunsan Chamsarang long-term care (LTC) facilities
      • Contact: Hyeonsuk An; Phone Number: +821020788428; Email: rkdxogns76@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to 3 long-term care (LTC) facilities

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
hospital length of stay	Linear Regression	The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
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.

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: delirium; dementia; mild cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 2019R1I1A3A0106056112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No