ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Descriptive-epidemiological analysis of health conditions
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of COVID-19
Exclusion Criteria
- •no informed consent
Outcomes
Primary Outcomes
Descriptive-epidemiological analysis of health conditions
Time Frame: 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 Outcomes
- Evaluation of frailty condition(At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge)
- Evaluation of drug consumption(At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge)
- Identification of biomarkers of inflammation(At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge)
- Assessment of functional capacity(At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge)
- Evaluation of inflamma-miRs(At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge)