COVID-19
Conditions
Keywords
COVID-19, older people, SARS-CoV-2, frailty, physical function, biomarkers of inflammation
Brief summary
The project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19. In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge. Results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.
Detailed description
Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people. Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge. In particular, the following specific pieces of information will be gathered: * routinely collected demographic, socioeconomic, clinical, biological and diagnostic data * frailty condition (by using the clinical frailty scale) * assessment of the functional capacities through ADL and IADL tests * health conditions; nutritional status; medications; treatments and procedures * biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.
Interventions
None listed
Sponsors
Istituto Nazionale di Ricovero e Cura per Anziani
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of COVID-19
Exclusion criteria
* no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive-epidemiological analysis of health conditions | Patients will be followed for the duration of hospital stay, an expected average of 20 days | Collection of a set of data and indicators of the health conditions including personal data, clinical care, biological and diagnostic data, treatments/procedures and drug therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of frailty condition | At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge | Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9) |
| Identification of biomarkers of inflammation | At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge | Analysis for IL6, IL-10, IL-2, IL-7, Alpha 1 Antitrypsin, IP10, MCP1, MIP1 alpha, TNF alpha, IFN alfa, IFN beta |
| Assessment of functional capacity | At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge | Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent) |
| Evaluation of drug consumption | At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge | Drugs prior to admission, drugs administered during hospital stay, prescribed drugs at discharge |
| Evaluation of inflamma-miRs | At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge | Determination of miR-21, miR-146a, miR-155 |
Countries
Italy
Contacts
Primary ContactAnna Rita Bonfigli, PhD
Outcome results
None listed