Abstract
Background: Despite the growing evidence on COVID-19, there are still many gaps in the understanding of this disease, especially in individuals in advanced age. We describe the study protocol of GeroCovid Observational, a multi-purpose, multi-setting and multicenter initiative that aims at investigating: risk factors, clinical presentation and outcomes of individuals affected by COVID-19 in acute and residential care settings; best strategies to prevent infection in long-term care facilities; and, impact of the pandemic on neuropsychologic, functional and physical health, and on medical management in outpatients and home care patients at risk of COVID-19, with a special focus on individuals with dementia.
Methods: GeroCovid involves individuals aged ≥60 years, at risk of or affected by COVID-19, prospectively or retrospectively observed since March 1 st , 2020. Data are collected in multiple investigational sites across Italy, Spain and Norway, and recorded in a de-identified clinical e-Registry. A common framework was adapted to different care settings: acute wards, long-term care facilities, geriatric outpatient and home care, and outpatient memory clinics.
Results: At September 16 th , 2020, 66 investigational sites obtained their Ethical Committee approval and 1618 cases (mean age 80.6 [SD=9.0] years; 45% men) have been recorded in the e-Registry. The average inclusion rate since the study start on April 25 th , 2020, is 11.2 patients/day. New cases enrollment will ended on December 31 st , 2020, and the clinical follow-up will end on June 30 th , 2021.
Conclusion: GeroCovid will explore relevant aspects of COVID-19 in adults aged ≥60 years with high-quality and comprehensive data, which will help to optimize COVID-19 prevention and management, with practical implications for ongoing and possible future pandemics.
Trial registration: NCT04379440 (clinicaltrial.gov).
Keywords: COVID-19; Health Services for the Aged; Inpatients; Nursing Homes; Observational Study; Outpatients.
【저자키워드】 COVID-19, observational study, outpatients, nursing homes, Inpatients, Health Services for the Aged, 【초록키워드】 pandemic, Risk factors, Study protocol, Infection, risk, outcome, Italy, clinics, memory, Dementia, Health, management, Spain, Pandemics, Nursing, age, Follow-up, multicenter, Norway, disease, Care, Evidence, Outpatient, Enrollment, individual, average, advanced age, help, approval, service, Inclusion, men, implication, risk of COVID-19, Prevent, physical, Committee, affected, collected, functional, recorded, New, home care patient, 【제목키워드】 Health, European, Assessing,