The GeroCovid e-Registry is a European de-identified clinical data electronic registry of geriatric patients at risk or suffering from COVID-19 (suspected and confirmed cases) observed since 1st March 2020 in the participating investigational sites.
Older adults (≥ 65 years) and pre-geriatric population (≥60 years and \<65 years) are the ones most at risk from complications of COVID-19, including increased mortality, possibly in relationship with their comorbidity and frailty status. The GeroCovid e-registry is intended to track Covid-19 pandemic impact on the general geriatric population and on age/care-setting related sub-populations. The analysis of results is expected to facilitate the adoption of optimal standard of geriatric care during the pandemic.
Study Type
OBSERVATIONAL
Enrollment
1,500
RSA La Quiete
Castiglione Cosentino, Calabria, Italy
RECRUITINGASP Catanzaro
Catanzaro Lido, Calabria, Italy
NOT_YET_RECRUITINGAOU Ferrara
Ferrara, Emilia-Romagna, Italy
Health status (WHO classification)
Change of health status according to WHO classification versus baseline after 60 days, or after any interval (last performed observation) in the event of early study termination (whole sample).
Time frame: 60 days or less in case of early termination
Incidence of Serious Adverse Events
Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events;
Time frame: 60 days or less in case of early termination
COVID-19 prevalent symptoms at onset
Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission
Time frame: Day0
COVID-19 Prognostic Factors
Most frequent chronic diseases (coded according MedDRA dictionary) as reported at hospital admission per Outcome (death; Serious Adverse Event other than death).
Time frame: Day0
Incidence of COVID-19 in the RSA cohort
Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application
Time frame: 60 days or less in case of early termination
Affective/mood state change from baseline in the " At home " cohort
Affective/mood state measured by the Geriatric Depression Scale 5-items (GDS-5) change from baseline; the GDS-5 ranges from 0 to 5, with scores\>2 suggesting depression
Time frame: 60 days or less in case of early termination
Cognitive function in the "Dementia" and "At home " cohorts
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Policlinico Campus Bio-Medico
Rome, Roma, Italy
RECRUITINGAOU Careggi
Florence, Tuscany, Italy
NOT_YET_RECRUITINGAOU Pisana Geriatria
Pisa, Tuscany, Italy
NOT_YET_RECRUITINGOspedale di Comunita' ULSS 6 Euganea- COVID Center
Camposampiero, Veneto, Italy
RECRUITINGMini Mental State Exam ( MMSE) change from baseline; the MMSE range from 0 to 30, with scores of 26 or higher being traditionally considered normal. Scores less than 9 generally indicate severe impairment, while scores between 10 and 20 indicate moderate dementia.
Time frame: 60 days or less in case of early termination
Daily Life Function in the "Dementia" and "At home " cohorts
Activities of Daily Life rating scale ( ADL) change from baseline; the ADL range from 6 to 0, 6 = High (patient independent) 0 = Low (patient very dependent)
Time frame: 60 days or less in case of early termination
Instrumental Daily Life function in the "Dementia" and "At home " cohorts
Instrumental Activities of Daily Life rating scale ( iADL) change from baseline; the iADL summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Time frame: 60 days or less in case of early termination
Residual signs and symptoms in the " Outcomes " cohort
Prevalence and pattern of residual signs and symptoms in the " Outcomes " cohort
Time frame: 60 days or less in case of early termination
Incidence of outcomes in the " Outcomes " cohort per Frailty Status
Incidence of Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Frailty Status at baseline (Fried's anamnestic criteria, adapted)
Time frame: 60 days or less in case of early termination
Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline
Incidence of outcomes (Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Comorbidity Burden at baseline (CIRS)
Time frame: 60 days or less in case of early termination