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.

Patrocinadores

Patrocinador principal: Universidad de Especialidades Espiritu Santo

Fuente Universidad de Especialidades Espiritu Santo
Resumen breve

This study aims to assess the prevalence and severity of dementia in an established cohort of community-dwelling older adults living in three neighboring rural Ecuadorian villages (Atahualpa, El Tambo, and Prosperidad), as well as to evaluate clinical and neuroimaging correlates of dementia in the study population. By the use of the Clinical Dementia Rating Scale (CDRS), the study also aims to assess the lower cutoff of the MoCA that better correlates with the occurrence of dementia in the study population. In addition, this study will provides grounds for the initiation of a prospective cohort study to assess factors influencing the development of dementia in the follow-up.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio June 1, 2019
Fecha de Terminación June 30, 2024
Fecha de finalización primaria June 30, 2020
Tipo de estudio Observational [Patient Registry]
Resultado primario
Medida Periodo de tiempo
To assess the prevalence and severity of dementia in the study population One year
To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population One year
To assess cognitive decline in the follow-up five years
Resultado secundario
Medida Periodo de tiempo
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 five years
Inscripción 600
Condición
Intervención

Tipo de intervención: Diagnostic Test

Nombre de intervención: Neuroimaging studies

Descripción: Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form

Etiqueta de grupo de brazo: The Three Villages Cohort

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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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Género: All

Edad mínima: 60 Years

Edad máxima: N/A

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos:
Universidad de Especialidades Espiritu Santo | Samborondon, Guayas, 092301, Ecuador Recruiting Oscar H Del Brutto, MD 593-997476984 [email protected]
Community Center | Atahualpa, Santa Elena, Ecuador Recruiting Bettsy Y Recalde, MD 59342907332 [email protected]
Ubicacion Paises

Ecuador

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Universidad de Especialidades Espiritu Santo

Nombre completo del investigador: Oscar H. Del Brutto

Título del investigador: Researcher

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: The Three Villages Cohort

Descripción: 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.

Datos del paciente Yes
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov