COVID-19
Conditions
Keywords
Coronavirus Electronic Registry Geriatrics Best Practices
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Italian Society of Gerontology and Geriatrics
BLUECOMPANION FRANCE
BLUECOMPANION LTD
Raffaele Antonelli Incalzi
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Applying only to the Acute Ward Patients cohort: 1. Hospitalised patients 2. Suspected or known SARS-CoV-2 infection 2. Applying only to the Nursing Homes (RSA) cohort: 1. Nursing Home Resident Older Adults 2. Suspected or known SARS-CoV-2 infection 3. Applying only to the Home and outpatients' care cohort: a. Outpatients at risk of SARS-CoV-2 infection 4. Applying only to the Dementia outpatients cohort: 1. Outpatients suffering from dementia according to NIA-AA criteria 2. At risk of SARS-CoV-2 infection 3. Ongoing treatment with anti-cholinesterase- dugs and/or anti-psychotics 5. Applying only to the At home cohort: a. Outpatients at risk of SARS-CoV-2 infection 6. Applying only to the Outcomes cohort: 1. Age≥65 years 2. Hospitalised patients diagnosed with SARS-CoV-2 infection
Exclusion criteria
1. Lack of a signed Informed Consent if the patient received and understood the information about the study. 2. Lack of a signed declaration by the responsible physician stating that no explicit opt-out advanced directives by the subject were known to be in place at the moment of inclusion if it had been impossible to inform the patient due to her/his state of consciousness and/or awareness of disease condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health status (WHO classification) | 60 days or less in case of early termination | 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). |
| Incidence of Serious Adverse Events | 60 days or less in case of early termination | Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of COVID-19 in the RSA cohort | 60 days or less in case of early termination | Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application |
| Affective/mood state change from baseline in the At home cohort | 60 days or less in case of early termination | 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 |
| Cognitive function in the Dementia and At home cohorts | 60 days or less in case of early termination | Mini 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. |
| Daily Life Function in the Dementia and At home cohorts | 60 days or less in case of early termination | 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) |
| COVID-19 prevalent symptoms at onset | Day0 | Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission |
| Residual signs and symptoms in the Outcomes cohort | 60 days or less in case of early termination | Prevalence and pattern of residual signs and symptoms in the Outcomes cohort |
| Incidence of outcomes in the Outcomes cohort per Frailty Status | 60 days or less in case of early termination | Incidence of Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Frailty Status at baseline (Fried's anamnestic criteria, adapted) |
| Incidence of outcomes in the Outcomes cohort per Comorbidity burden at baseline | 60 days or less in case of early termination | Incidence of outcomes (Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Comorbidity Burden at baseline (CIRS) |
| Instrumental Daily Life function in the Dementia and At home cohorts | 60 days or less in case of early termination | 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. |
| COVID-19 Prognostic Factors | Day0 | Most frequent chronic diseases (coded according MedDRA dictionary) as reported at hospital admission per Outcome (death; Serious Adverse Event other than death). |
Countries
Italy
Contacts
Primary ContactSusanna Del Signore, M.D.
Outcome results
None listed