- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Xi-jian Dai, PhD
- 전화번호: 13755756959
- 이메일: daixjdoctor@126.com
연구 장소
-
-
Jiangxi
-
Nanchang, Jiangxi, 중국, 330006
- 모병
- Second Affiliated Hospital of Nanchang University
-
연락하다:
- Xi-jian Dai
- 전화번호: 13755756959
- 이메일: daixjdoctor@126.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Dementia
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .