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Seniors-ENRICA: Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

Sponsor
Universidad Autonoma de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT02804672
Collaborator
(none)
1,566
Enrollment
1
Location
111
Actual Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1566 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain
    Actual Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Frailty [3 years]

      Method of assessment: Fried criteria

    Secondary Outcome Measures

    1. Change from baseline in Cardiovascular health [3 years]

      Method of assessment: 7 cardiovascular health metrics as defined by American Heart Association

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Non-institutionalized Spanish resident

    • 60 years and over

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid Madrid Spain 28029

    Sponsors and Collaborators

    • Universidad Autonoma de Madrid

    Investigators

    • Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
    • Principal Investigator: Jose R Banegas, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernando Rodríguez-Artalejo, Professor of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
    ClinicalTrials.gov Identifier:
    NCT02804672
    Other Study ID Numbers:
    • Seniors-ENRICA
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    May 1, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Fernando Rodríguez-Artalejo, Professor of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
    Cardiovascular health
    Diet
    Functional limitations
    Frailty
    Older adults
    Additional relevant MeSH terms:
    Frailty

    Study Results

    No Results Posted as of May 1, 2019