- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05113446
MDD(Mild Cognitive Impairment Delirium Dementia) Cohort
28. juli 2022 opdateret af: Kyoung ja Moon, Keimyung University Dongsan Medical Center
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
163
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kyoung ja Moon, doctor
- Telefonnummer: +821023026302
- E-mail: kjmoon2150@gmail.com
Undersøgelse Kontakt Backup
- Navn: min a Park
- Telefonnummer: +821023026302
- E-mail: kjmoon2150@gmail.com
Studiesteder
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Gyeongsangnam-do,
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Daegu, Gyeongsangnam-do,, Korea, Republikken, 50572
- Rekruttering
- Yangsan Seoul long-term care (LTC) facilities
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Kontakt:
- YooJeong Yang
- Telefonnummer: 821054258230
- E-mail: hp79797@naver.com
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Jeollabuk-do
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Daegu, Jeollabuk-do, Korea, Republikken, 54078
- Ikke rekrutterer endnu
- Gunsan Chamsarang long-term care (LTC) facilities
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Kontakt:
- Hyeonsuk An
- Telefonnummer: +821020788428
- E-mail: rkdxogns76@naver.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients admitted to 3 long-term care (LTC) facilities
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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MCI(Mild Cognitive Impairment) group
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Delirium incidence in participants with mild cognitive impairment
Tidsramme: 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.
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descriptive statistics
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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.
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Dementia conversion rate and transition period in participants with mild cognitive impairment
Tidsramme: 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.
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descriptive statistics
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Risk factors affecting participants' delirium
Tidsramme: 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.
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Logistic Regression
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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.
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Mortality
Tidsramme: It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.
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Kaplan-Meier survival, Cox proportional hazard regression, Logistic Regression
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It is statistically calculated in 30-day, 60-day, 12-month, 24-month, and 36-month increments.
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hospital length of stay
Tidsramme: The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
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Linear Regression
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The period from hospitalization to discharge is calculated in days and analyzed in units of 12 months.
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healthcare costs
Tidsramme: 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.
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Linear Regression
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2021
Primær færdiggørelse (Forventet)
31. oktober 2022
Studieafslutning (Forventet)
31. december 2025
Datoer for studieregistrering
Først indsendt
17. oktober 2021
Først indsendt, der opfyldte QC-kriterier
28. oktober 2021
Først opslået (Faktiske)
9. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019R1I1A3A0106056112
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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Kliniske forsøg med Delirium
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Alexandria UniversityAfsluttetClozapinforgiftning | Hypoaktivt delirium | Tricyklisk antidepressiv forgiftning | Antikolinerg delirium | Antipsykotisk Toksicitet | CNS-depression | Procyclidininduceret deliriumEgypten
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Duke UniversityIkke rekrutterer endnuDelirium Forvirringstilstand | Hyperaktivt delirium | Delirium på intensivafdelingen | Agiteret deliriumForenede Stater
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Efficacy Care R&D LtdHadassah Medical OrganizationUkendtDelirium | Delirium, årsag ukendt | Delirium af blandet oprindelse | Delirium Forvirringstilstand | Delirium lægemiddel-induceretIsrael
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicAfsluttetDelirium i alderdommen | Delirium af blandet oprindelse | Delirium overlejret på demens | Delirium ForvirringstilstandNorge
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Sengkang General HospitalRekrutteringDelirium og postoperativ kognitiv dysfunktion (POCD) | Delirium, postoperativt | Delirium - PostoperativtSingapore
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Universitat de LleidaHospital d'IgualadaIkke rekrutterer endnuDelirium i alderdommen | Delirium behandling | Delirium ForvirringstilstandSpanien
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Johns Hopkins UniversityNational Institute on Aging (NIA)AfsluttetDelirium | Delirium på Emergence | Høretab | Høretab, højfrekvent | Høretab, sensorineural | Delirium, årsag ukendt | Høretab, bilateralt | Hørehandicap | Delirium i alderdommen | Delirium af blandet oprindelse | Delirium overlejret på demens | Delirium Forvirringstilstand | Delirium med demens | Høretab, Funktionel | Høretab... og andre forholdForenede Stater
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Universidad de SantanderUkendtDelirium af blandet oprindelse | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Wonkwang University HospitalAfsluttet
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Beth Israel Deaconess Medical CenterMassachusetts General Hospital; Columbia University; Ohio State UniversityRekrutteringDelirium i alderdommen | Delirium, postoperativtForenede Stater
Kliniske forsøg med Delirium assessment using S-CAM
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Istanbul UniversityAfsluttetPostoperativt deliriumKalkun
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First Affiliated Hospital of Zhejiang UniversityTilmelding efter invitationPostoperativt delirium (POD) | ElektroencefalogramKina
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Hospices Civils de LyonAfsluttet
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Brno University HospitalMasaryk University; Department of Neurology, University Hospital BrnoIkke rekrutterer endnu
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Penn State UniversityBeth Israel Deaconess Medical Center; Mount Nittany Medical Center; Penn...RekrutteringDelirium | Delirium i alderdommen | Delirium overlejret på demens | Delirium med demensForenede Stater
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Ain Shams UniversityIkke rekrutterer endnu
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Afsluttet
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Masaryk UniversityBrno University Hospital; University Hospital, MotolRekruttering
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University of Modena and Reggio EmiliaUkendtDemens | Grå stær | Senil grå stær | Mild kognitiv svækkelse | Post-Op komplikation | Delirium i alderdommen | Delirium Forvirringstilstand | Grå stær i alderdommenItalien
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Ohio State UniversityAfsluttetDeliriumForenede Stater