Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years (NEDICES2RISK)

Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years: an Estimation Model Based on Spanish Population. NEDICES-2-RISK Study.

This study assesses whether people's cardiovascular risk influences cognitive performance in later years. To do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.

Study Overview

• Status: Unknown
• Conditions: Risk Factor, Cardiovascular; Cognitive Decline
• Intervention / Treatment: Other: Classification according to the cardiovascular risk

• Study Type: Observational
• Enrollment (Anticipated): 965

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28033
    • Gerencia Atencion Primaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.

Description

Inclusion Criteria:

• population aged 55 to 74 years from NEDICES 2 study
• to have signed informed consent
• to have done the neuropsicological assessment

Exclusion Criteria:

• to have a dementia diagnosis at baseline.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the 37-item versión of the Mini-Mental State Examination score	The 37 item Version of the Mini-Mental State Examination is a Spanish adapted version of the original MMSE by Folstein. It contains 37 items. Includes temporal and spatial orientation, memory, attention, calculus, language, object recognition, elementary commands and visuoconstructive capacity. The minimun score is 0 and the maximum score is 37 points. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Clock-drawing test score	The Clock-drawing test is a brief test that explores comprehension, concentration, visual memory and abstraction and visuoconstructive praxis. The subject is asked to draw a clock from memory on a blank sheet, including the numbers and hands at a fixed time. The minimum score is 0 and the maximum score is 4. Higher values are considered a better outcome. Performance time is recorded. A shorter time is considered a better outcome.	Baseline and 5 years
Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score	The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening instrument for depression, self-administared, which records depressive symptoms and their different manifestations in the last 7 days and each symptom is classified in four frequency levels. The score ranges from 20 to 80. Higher values are considered a worse outcome.	Baseline and 5 years
Change in the Semantic verbal fluency test score	The Semantic verbal fluency test evaluates semantic memory, executive and verbal planning capabilities. It is used a shorter version that evaluates the number of elements in a category (animals). There is a minimum score of 0, there is not a maximun score. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Six-object memory recall test score	The Six-Object Memory Recall Tests shows six sheets with common objects and explores object recognition, immediate recall and delayed memory after 5 minutes. Both, object recognition, inmediate recall and delayed memory have a scale ranging from 0 to 6.Therefore, the total score has a minimun score of 0 and a maximum score of 18 points. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Mental Function Index score	The Mental Function Index is a questionnaire that evaluates 11 instrumental activities of daily life and competencies in the home and occupational and social functioning that is administered to a family member or caregiver. It explores 11 sections, each one with three levels of functionality. The minimum score is 0 and the maximum score is 33. Higher values are considered a worse outcome.	Baseline and 5 years
Change in the Trail Making Test score	The Trail Making Test is a visuomotor integration test from which is collected the score, the number of mistakes and the performance time. The score ranges from 1 to 20. Higher values are considered a better outcome. A shorter performance time and fewer mistakes are considered a better outcome.	Baseline and 5 years
Change in the Word accentuation test score	The Word accentuation test is a verbal intelligence test in which the participant reads 30 unusual words that are shown to him without tildes and whose accentuation he has to do correctly. The score ranges from 0 to 30. Higher values are considered a better outcome.	Baseline and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New cases of cancer during the 5-years follow-up	It will be recorded all new cases of cancer during the 5-years follow-up	5 years

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Investigators: Principal Investigator: Ester Tapias-Merino, MD, Gerencia de Atención Primaria, Madrid

Publications and helpful links

General Publications

• Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon J. Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study. JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: April 21, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prevention; cognitive aging; Cardiovascular risk prediction models; Framingham risk function; FRESCO risk function; risk function
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PI18/00522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No