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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Guayas
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Samborondon、Guayas、エクアドル、092301
- 募集
- Universidad de Especialidades Espiritu Santo
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コンタクト：
- Oscar H Del Brutto, MD
- 電話番号：593-997476984
- メール：odelbrutto@uees.edu.ec
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コンタクト：
- Bettsy Y Recalde, MD
- 電話番号：59342907332
- メール：bettsyr@hotmail.es
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Santa Elena
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Atahualpa、Santa Elena、エクアドル
- 募集
- Community center
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コンタクト：
- Bettsy Y Recalde, MD
- 電話番号：59342907332
- メール：bettsyr@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To assess the prevalence and severity of dementia in the study population
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 201901UEES
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
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