- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07676851
Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression
Development of a Clinical Risk Score Prediction Tool for 5-, 9-, and 13-year Risk of Dementia Among Late-life Population With Depression: a Longitudinal Cohort Study
The goal of this observational study is to learn about the ability of a point risk score prediction model, developed using electronic medical record data, to predict the risk of progression from geriatric depression to dementia in older Chinese adults. The main questions it aims to answer are:
Does a higher point risk score increase the risk of developing dementia in older adults with depression?
What is the accuracy of the point risk score prediction model in identifying individuals at high risk of dementia among older adults with depression?
Participants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. The research team will collect data from their electronic medical records, including depression diagnoses, dementia diagnoses, comorbidities, medication records, and follow-up information. The point risk score will be calculated based on these routinely collected clinical data.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Xi-jian Dai, PhD
- Telefonnummer: 13755756959
- E-post: daixjdoctor@126.com
Studiesteder
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Rekruttering
- Second Affiliated Hospital of Nanchang University
-
Ta kontakt med:
- Xi-jian Dai
- Telefonnummer: 13755756959
- E-post: daixjdoctor@126.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adults aged ≥50 years.
- A diagnosis of depression clearly recorded by a clinician in the electronic medical record at baseline (based on structured or unstructured diagnostic documentation formed through routine clinical practice).
- Complete baseline electronic medical record data available, including at least demographic information (age, sex), clinical diagnoses, comorbidities, and medication records.
- At least one follow-up record available in the electronic medical record system to enable determination of incident dementia outcomes.
- Informed consent provided for the use of routine medical data for this research analysis.
Exclusion Criteria:
- Any type of dementia diagnosis recorded in the electronic medical record at baseline (including Alzheimer's disease, vascular dementia, and other types of dementia).
- Medical record documentation indicating that the diagnosis of dementia preceded the diagnosis of depression, or an inability to clearly determine the chronological order of the two diagnoses.
- Presence of other neurological diseases at baseline that may independently cause severe cognitive impairment (e.g., Parkinson's disease, multiple sclerosis, brain tumor, normal pressure hydrocephalus).
- Missing key baseline electronic medical record data that would preclude subsequent risk model analysis.
- Incomplete follow-up information or inability to clearly confirm incident dementia outcomes through the electronic medical record system.
- Refusal to participate in the study or withdrawal of informed consent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Dementia Group
Participants who received a first diagnosis of dementia during the follow-up period.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
|
Non-Dementia Group
Participants with no diagnosis of dementia during the follow-up period.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Dementia
Tidsramme: Baseline through study completion, average 10 years
|
New-onset dementia in older adults with depression, defined by clinician-recorded dementia diagnosis in electronic medical records (including Alzheimer's disease, vascular dementia, and other types of dementia).
|
Baseline through study completion, average 10 years
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIT-2024-194
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .