- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04123171
Cerebrovascular Correlates of Dementia in Rural Communities - The Three Villages Study
Cerebrovascular Correlates of Dementia in Community-dwelling Older Adults Living in Remote Rural Communities - The Three Villages Study. Methodology and Operational Definitions.
연구 개요
상세 설명
The Three Villages Study is a population-based prospective cohort study designed to reduce the increasing burden of cognitive decline and dementia in rural Ecuador. Before the study, our Executive Committee met with community leaders to explain the aims of the study and to learn about the culture and traditions of villagers. Field personnel were trained to assure uniformity in data collection. With the aid of satellite view (Google Earth, Google Inc., Mountain View, CA), updated sketches of the villages were performed to identify blocks and houses.
The study initially will follow a 3-Phase cross-sectional design. During Phase I, Atahualpa, El Tambo, and Prosperidad residents aged 60 years or more will be identified by means of a door-to-door survey and interviewed with validated questionnaires to identify those with relevant risk factors and suspected conditions of interest. In Phase II, certified neurologists will examine suspected cases as well as random samples of negative individuals, to assess reliability of field instruments and to determine prevalence of the investigated conditions. In Phase III, enrolled individuals will be invited to undergo complementary tests. Thereafter, incoming residents will be recruited and followed-up by means of yearly door-to-door surveys and other overlapping sources to estimate incidence of the disorders of interest.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Guayas
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Samborondon, Guayas, 에콰도르, 092301
- 모병
- Universidad de Especialidades Espiritu Santo
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연락하다:
- Oscar H Del Brutto, MD
- 전화번호: 593-997476984
- 이메일: odelbrutto@uees.edu.ec
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연락하다:
- Bettsy Y Recalde, MD
- 전화번호: 59342907332
- 이메일: bettsyr@hotmail.es
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Santa Elena
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Atahualpa, Santa Elena, 에콰도르
- 모병
- Community center
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연락하다:
- Bettsy Y Recalde, MD
- 전화번호: 59342907332
- 이메일: bettsyr@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria: Individuals aged 60 years of more residing in Atahualpa, El Tambo, and Prosperidad, who signed a comprehensive informed consent form.
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Exclusion Criteria: Severely disabled individuals in whom interviews and procedures cannot be performed
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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The Three Villages Cohort
Individuals aged 60 years or more identified by means of door-to-door surveys, living in Atahualpa, El Tambo, and Prosperidad.
Individuals will be interviewed with validated field instruments, and there will be invited for the practice of complementary exams to recognize markers of aterosclerosis and cerebral small vessel disease.
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Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To assess the prevalence and severity of dementia in the study population
기간: One year
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The Clinical Dementia Rating Scale will be applied to all participants
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One year
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To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population
기간: One year
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Neuroimaging studies, ultrasound examination of extracranial carotid arteries, and ankle-brachial index determinations will be used to assess the presence of large vessel aterosclerosis and cerebral small vessel disease in the study population
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One year
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To assess cognitive decline in the follow-up
기간: five years
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Enrolled individuals will be prospectively followed every year for up to five years, and will be re-assessed to determine the progression of cognitive impairment and its relationship with markers of aterosclerosis and cerebral small vessel disease
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five years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To assess cutoffs of the Montreal Cognitive Assessment useful to differentiate normal cognitivion from mild cognitive impairment, and mild cognitive impairment to dementia in the study population
기간: five years
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The MoCA was mainly designed to separate normal individuals to those with MCI.
However, a major limitation of the MoCA is its lack of accuracy for identifying persons with dementia.
Therefore, the use of more complex field instruments (yet, feasible to apply in individuals living in rural settings) is needed to determine the burden of dementia and its cerebrovascular correlates in rural communities.
In this regard, the Clinical Dementia Rating Scale (CDRS) is a useful tool to assess people living in these settings for establishing the burden and severity of dementia as well as to further assess clinical and neuroimaging correlates of this condition.
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five years
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Del Brutto OH, Penaherrera E, Ochoa E, Santamaria M, Zambrano M, Del Brutto VJ; Atahualpa Project Investigators. Door-to-door survey of cardiovascular health, stroke, and ischemic heart disease in rural coastal Ecuador--the Atahualpa Project: methodology and operational definitions. Int J Stroke. 2014 Apr;9(3):367-71. doi: 10.1111/ijs.12030. Epub 2013 Mar 19.
- Del Brutto OH, Mera RM, Peralta LD, Hill JP, Generale LM, Torpey AP, Sedler MJ. Cardiovascular Health Status Among Community-Dwelling Ecuadorian Natives Living in Neighboring Rural Communities: The Three Villages Study. J Community Health. 2020 Feb;45(1):154-160. doi: 10.1007/s10900-019-00728-4.
- Del Brutto VJ, Ortiz JG, Del Brutto OH, Mera RM, Zambrano M, Biller J. Total cerebral small vessel disease score and cognitive performance in community-dwelling older adults. Results from the Atahualpa Project. Int J Geriatr Psychiatry. 2018 Feb;33(2):325-331. doi: 10.1002/gps.4747. Epub 2017 May 26.
- Del Brutto OH, Mera RM, Del Brutto VJ, Sedler MJ. The bicaudate index inversely associates with performance in the Montreal Cognitive Assessment (MoCA) in older adults living in rural Ecuador. The Atahualpa project. Int J Geriatr Psychiatry. 2016 Aug;31(8):944-50. doi: 10.1002/gps.4419. Epub 2016 Feb 2.
- Del Brutto OH, Mera RM, Castillo PR, Del Brutto VJ. Key findings from the Atahualpa Project: what should we learn? Expert Rev Neurother. 2018 Jan;18(1):5-8. doi: 10.1080/14737175.2018.1400382. Epub 2017 Nov 6. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201901UEES
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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