MDD(Mild Cognitive Impairment Delirium Dementia) Cohort

NCT05113446 | Unknown

• 1 other identifier: 2019R1I1A3A0106056112
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 2

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.

Conditions

Delirium; Mild Cognitive Impairment; Dementia

Keywords

delirium; mild cognitive impairment; dementia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

• Mortality

  It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.

• hospital length of stay

  The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.

• 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.

Study Arms (1)

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

Interventions

Delirium assessment using S-CAM DIAGNOSTIC_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

MCI(Mild Cognitive Impairment) group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (2)

Yangsan Seoul long-term care (LTC) facilities

Daegu, Gyeongsangnam-do, 50572, South Korea

RECRUITING

Gunsan Chamsarang long-term care (LTC) facilities

Daegu, Jeollabuk-do, 54078, South Korea

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39511473 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Kyoung ja Moon, doctor

CONTACT

+821023026302; kjmoon2150@gmail.com

min a Park

CONTACT

+821023026302; kjmoon2150@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 9, 2021
• Study Start: July 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2025
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

KR (2)