Following enrollment, participants will be seen by the study teams at baseline (i.e. at discharge from participating wards) and at 6 and 12 months at a face-to-face meeting. Demographic data and socioeconomic status (occupation before retiring, economic status, formal and informal care) will be documented and followed up at each visit. Physical examination will be performed by medical doctors according to standardized procedure given in the visit protocol. Medical history and use of medication and adverse drug reactions classified according to the World Health Organization (WHO) definition [64] will be collected in each visit. During all face-to-face, visits a comprehensive geriatric assessment (CGA) will be performed using the instruments described in Table Table11.

An ad-hoc resource use questionnaire was developed using a 3-month recall time-frame, to retrieve the following information by interviewing patient and/or caregiver: physician visits (general practitioners, specialists, or physician at the Emergency Room), use of diagnostic tests and specialist clinic procedures, use of care services (e.g. nurse home visit, physiotherapy, home help, social transport, day care center) and hospital admissions (number and duration of hospitalization, type of reimbursement).

During enrollment and 12-month follow-up visits blood and urine samples will be collected for biomarkers assessment (see “Laboratory parameters and biomarkers”). During COVID-19 outbreak, follow-up visits were stopped, and as a consequence, 67 patients were missing at FU. Nevertheless, the number of patients completing the study was 456, which is in keeping with the sample size calculation.

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