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on a combination of socio-demogra- serious outbreaks of the infection in
phic, historical, clinical, neurological nursing homes, such as the one loca-
and neuropsychological, biological ted in the CAFRS, all of which forced
(from blood tests) and neuroimaging the lockdown of the population for se-
(various forms of 3T MRI). veral months. The study of the Vallecas
Project volunteers had to be suspen-
The participant recruitment phase for ded for safety reasons, especially of the
the Vallecas project lasted from Oc- participating volunteers.
tober 2011 to December 2013. By then,
1,213 individuals of both genders, aged In these circumstances, during the
70-85 years were recruited and evalua- month of May 2020, a telephone sur-
ted at baseline. Once included in the vey was designed and carried out in
study, the project conducts an annual which most of the Vallecas Project
follow-up for five years to assess the volunteers were contacted (913 volun-
evolution profile of all participants, teers, 90%) and the incidence, seve-
specifically identifying those that rity, mortality, clinical symptoms and
develop cognitive impairment and/or risk factors of COVID-19 in this cohort
dementia. At the beginning of 2018, an of elderly were established, and their
agreement was signed between the relationship with the type of residence
CIEN Foundation and the Queen Sofia and cognitive function. This telephone
Foundation to extend the duration of survey was also useful to reestablish
the Vallecas Project beyond the five contact with some of the volunteers
years of follow-up originally planned. who had left the project and to gather
This second phase covered by the new information on their current cognitive
agreement will allow the cohort to be and functional status.
followed for an additional four-year
period.
4.3.1. Baseline evaluation
At the beginning of 2020, the sixth
follow up visit for the whole cohort Before entering the study, volunteers
had been completed, were approa- interested in participating in it were
ching the end of the seventh, mid-way subjected to an initial assessment to
through the eighth and just starting determine whether they meet the
the ninth one. Regular monitoring of criteria for inclusion and/or whether
the cohort was sharply affected from an exclusion criterion exists. Overall, all
March 2020 onwards by the outbreak volunteers were required to meet four
of the SARS-Cov-2 virus, the expansion inclusion criteria to be considered for
of the COVID-19 pandemic, with espe- entering the study:
cially marked morbidity and mortali-
ty in the elderly population, and the • Signing an informed consent.
Cien Foundation annual report 2020 104
