key: cord-0819343-m1192rdl
authors: Trevisan, Caterina; Del Signore, Susanna; Fumagalli, Stefano; Gareri, Pietro; Malara, Alba; Mossello, Enrico; Volpato, Stefano; Monzani, Fabio; Coin, Alessandra; Bellelli, Giuseppe; Zia, Gianluca; Ranhoff, Anette Hylen; Antonelli Incalzi, Raffaele
title: Assessing the impact of COVID-19 on the health of geriatric patients: The European GeroCovid Observational Study
date: 2021-01-31
journal: Eur J Intern Med
DOI: 10.1016/j.ejim.2021.01.017
sha: cfcc01bcb610e6fd07d60d197d5153342275d168
doc_id: 819343
cord_uid: m1192rdl

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).

Older adults have been the part of the population most burdened by Covid-19 pandemic. Indeed, the disease mortality rate was reported to rise, in men and women, from 4.6% and 2.5% among those aged 30-39 years to 61% and 48% in individuals older than 80 years, respectively [1] . The age-related trend in mortality and the greater vulnerability of the male gender were confirmed worldwide [2] [3] [4] .

Multimorbidity and frailty, whose prevalence increases with age [5, 6] , were supposed to partly explain the worse Covid-19 prognosis in advanced age [2, [7] [8] [9] . -Inflammaging‖, which is characterized by a complex, abnormal pattern of immune alterations promoting inflammation over a worthwhile immunologic response, is another possible cause of the age-related increased vulnerability to Covid-19 [10, 11] . The cytokine storm, an ominous hallmark of the response to Covid-19, may also be more likely present and exacerbated in older people [10, 12] . Apart from pathophysiologic aspects, it cannot be excluded that shortage of resources sometimes prompted to prioritize young and adult patients care, relatively limiting the access of older individuals to more intensive settings of care. In addition, it is possible that atypical presentations of Covid- 19 , deferring recognition and appropriate care, may have further complicated the clinical management of older patients [13] .

It is also important to recognize that a considerable fraction of the excess mortality in older people has been related to poor logistic plans and organization of long-term care facilities, which made the residents at very high risk of infection and inadequate care [14, 15] . Insufficient attention to appropriate disinfection practices and the shortage of protective equipment for the staff further contributed to make the nursing home an -at risk‖ setting for older individuals [16] .

Finally, the Covid-19 pandemic affected the quality of care also of non-Covid-19 geriatric patients, especially those with dementia and psychiatric disorders, who were more likely to be burdened by the adverse effects of the loss of social contacts and continuous medical monitoring [17, 18] . Even if difficult to quantify, the influence of pandemic on older multimorbid non-Covid-19 individuals determined relevant consequences, as shown by the dramatic increase of mortality after acute myocardial infarction and by the sharp worsening of psychiatric disorders observed after the beginning of the lockdown phase [19, 20] .

The Italian Society of Gerontology and Geriatrics, in collaboration with the Spanish and the Norwegian Societies of Geriatrics, planned a multi-setting, multi-national and multi-scope registry, the Geriatric Population COVID-19 (GeroCovid) Observational Study, aimed at pursuing the following main objectives:

to assess age-related changes in risk profile, clinical presentation, needs of care, and short-and mediumterm outcomes of Covid-19 patients aged ≥60 years, in acute and residential settings;

to explore the impact of the pandemic on the functional ability, cognitive, psychological and behavioral status of non-Covid-19 individuals aged ≥60 years, with special attention to patients with dementia;

to identify the adaptive strategies used by outpatient and home care services to compensate for the limitation of contacts imposed by the Covid-19, with a focus on telemonitoring;

to investigate the healthcare measures taken in long-term care facilities to prevent and contrast the Covid-19 pandemic.

This article describes the GeroCovid study protocol and provides a comprehensive overview of the methods, metrics and expected results of the project.

GeroCovid is an observational retrospective-prospective study involving adults aged ≥60 years, evaluated during the Covid-19 pandemic. The choice of this age limit will allow us to explore the study outcomes both in adults in working-age approaching retirement and those in more advanced age, capturing possible differences in risk factors, clinical course, prognosis, and burden of Covid-19. Moreover, such cut-off is currently used in several demographic statistics that report health-related data in the general population divided by 10-year age groups [21] .

The study has been promoted by the Italian Society of Gerontology and Geriatrics and involves multiple investigational sites across Italy, Spain, and Norway. GeroCovid includes cases observed since March 1 st , 2020. Enrollment will end on December 31 st , 2020 and the clinical follow-up of prospective cases on June 30 th , 2021. The study is registered in clinicaltrial.gov (Trial Registration: NCT04379440).

GeroCovid was designed by the Italian Society of Gerontology and Geriatrics, in collaboration with Bluecompanion, which has developed and adapted a dedicated electronic registry to collect and harmonize clinical data from the different care settings. Based on the setting, the study has been structured into six main research cohorts: GeroCovid acute wards, GeroCovid home and outpatients' care, GeroCovid dementiadrug monitoring, GeroCovid dementiapsychological health, GeroCovid long-term care facilities (LTCFs), and GeroCovid outcomes. The GeroCovid coordinating group involves clinicians specialized in geriatric medicine, experts in epidemiology, and ICT experts. This multidisciplinary group includes the coordinators of the different project cohorts. Under the supervision of the GeroCovid Principal Investigator (RAI) and the support of the methodological team (SDS, GZ), the cohorts' coordinators closely monitor the research activities of the involved sites, including the enrollment of the study participants and the data collection.

Since March 2020, the coordinating group is meeting through weekly videoconferences to discuss together the development and optimization of GeroCovid research activities, and to find solutions to possible concerns related to the study.

GeroCovid is a multicentre and multi-setting study whose primary endpoint is represented by changes in health status, defined according to World Health Organization (WHO) classification [22] and based on the incidence of hospitalizations, Serious Adverse Events (SAE) and death. The settings and the specific primary and secondary objectives for each GeroCovid cohort are reported in Table 1 .

The GeroCovid study is consecutively enrolling individuals aged ≥60 years with or at risk of Covid-19, either retrospectively or prospectively observed. The "risk" of getting SARS-CoV-2 infection or of experiencing the negative effects of the pandemic, was specified in each setting. Of the six GeroCovid cohorts, two consider only Covid-19 patients during the hospital stay (GeroCovid acute wards) and after hospital discharge (GeroCovid outcomes). The GeroCovid LTCFs cohort involves both residents affected by Covid-19 and those at risk of getting SARS-CoV-2 infection according to suspected symptoms or contacts with Covid-19 confirmed cases. The risk of experiencing the negative effects of the pandemic was applied to the GeroCovid home and outpatients' care, GeroCovid dementiadrug monitoring, and GeroCovid dementiapsychological health cohorts, which include, respectively, home-dwelling patients on geriatric home care and outpatients with dementia referred to memory clinic. Further details on the inclusion criteria for each GeroCovid cohort are reported in Table 1 . Instead, exclusion criteria are: lack of signed informed consent to participate in the study; and, in case of impossibility to inform the patient due to her/his state of consciousness and/or awareness of disease condition, lack of a signed declaration by the investigator attesting that no explicit opt-out advanced directives by the subject existed at the inclusion in the registry.

Trained physicians with expertise in geriatric medicine are collecting GeroCovid participants' data in a specifically designed e-Registry, accessible through a dedicated online platform (details on the e-Registry can be found below, under -Data management and quality assurance‖). Data collection in the GeroCovid e-Registry is organized in five main sections, to describe both the healthcare infrastructures (specialized Covid-19 hospitals, long-term care facilities, etc.) and the features of single cases observed across different care settings.

In the first step, the local coordinator of each site registers and describes his/her centre in the online platform. In this phase, information is given about the type (e.g., acute/post-acute ward for Covid-19 patients, outpatient clinic, memory clinic, long-term care facility) and the characteristics (e.g., number of beds, type and number of healthcare personnel, etc.) of the structure, the date in which the observation period started, the preventive measures implemented during the Covid-19

pandemics (e.g., adoption of strict limitations to family visits to patients, reduction of non-urgent specialist consultations, body temperature monitoring, isolation of suspected and confirmed Covid-19 cases).

For each GeroCovid patient, investigators collect information on his/her demographic characteristics, household setting, pre-Covid-19 lifestyle (smoking and drinking habits, mobility function and physical activity level), chronic diseases, nutritional status, frailty (using adapted criteria from Pedone et al., 2016 [23] , and Fried et al., 2001 [5] ), regularly used pharmacological treatments (coded through the ATC classification), ongoing or previous (until less than three months) hormonal replacement therapy, and previous influenza, anti-pneumococcal and anti-herpes zoster vaccinations. The main patient's diagnosis (and the initial hospital admission diagnosis, only for the GeroCovid acute wards patients who were originally hospitalized due to non-Covid-19 diseases), observation start and end dates, and type of outcome (classified as no major change, clinical improvement, serious adverse event, death, transfer to a different hospital, withdrawal) are also collected. Finally, recorded data also concern the impact of Covid-19 pandemics and physical distancing on social interactions, assistance in daily activities, care provision, psychological reaction and changes in care setting.

Observational phases. For each participant, investigators fill two or more observation modules corresponding to different disease-or evaluation-phases. Each observational module includes the following information: evaluation date and patient health status according to WHO classification [22] , vital signs (blood pressure and heart rate), physical examination (general conditions and system-specific evaluation), anthropometry and nutritional status, diagnosis tests for SARS-CoV-2 infection (date and result of nasopharyngeal swab and/or serological tests), arterial blood gas test results, main findings at x-ray and/or computerized tomography scans, blood/urine analyses (including hematology, lipids, biochemistry, inflammatory and cardiac biomarkers, coagulation, thyroid hormones, hepatitis C screening, urine analysis), electrocardiographic test results, Covid-19-like symptoms and date of onset, procedures related to suspected Covid-19 clinical pattern, and updates of the pharmacological therapy.

Adverse events. Onset date, type (coded according to MedDRA classification), severity and outcomes of possible adverse event occurred during the observation period are recorded for each participant.

Specific evaluation scales. Specific information and evaluation scales for each GeroCovid cohort are also collected in the e-Registry. Details in this regard are reported in Table 2 .

The data collection of GeroCovid is performed in a European de-identified clinical data electronic registry.

The GeroCovid e-Registry was adapted from an existing electronic platform that Bluecompanion developed in 2018 for a project called e-Trajectories. In March 2020, in conjunction with the Covid-19 pandemic, Bluecompanion made their health data collection system available to the GeroCovid initiative. E-Trajectories and its Gerocovid adaptation are based on the CleanWeb engine produced by Telemedicine Technologies sessions and dummy data entry on a -training‖ environment before being allowed to data entry into the production environment.

Sample size. For each GeroCovid cohort, the sample size was estimated through formal computation or following a purposive sampling strategy, depending on the specific primary outcomes and on the availability of literature data to suppose the expected effect size. Details for the estimated sample size in each GeroCovid cohort are summarized in Table 2 .

Data analysis. Continuous variables will be described as mean ± standard deviation or median and interquartile range in the case of a not normal distribution. Categorical variables will be reported as frequency values and percentages. Quantitative variables will be compared with Student's t-test and analysis of variance, or the related non-parametric tests (Mann-Whitney or Kruskal-Wallis test) after having shown a non-normal distribution. The Chi-squared or Fisher's test will be used for the categorical variables. Based on the study hypothesis, the association between exposures and outcome of interest will be tested, as appropriate, using linear or logistic regression models, Kaplan-Meier analysis or Cox regressions, and linear mixed models in the case of repeated measures over time. Possible differences by age class (60-64; 65-74, 75-84, ≥85 years) and sex in the study outcomes will be evaluated through interaction tests and stratified analyses.

The Gerocovid Observational study overarching protocol was reviewed and approved by the Campus Bio-Medico University Ethical Committee in April 2020. All participating investigational sites further submitted relevant sub-protocols to their competent local Ethical Committee and institutional review boards, as applicable, according to the Italian legislation. All investigators and the ICT team accepted to work according to the GCP (ICH E6-R2). Written or dematerialized informed consent was obtained by each patient. Alternatively, a written declaration was kept on file by the local investigator, which responded to applicable derogations during the pandemic.

All individual clinical data were anonymized before data entry. Collected data are protected and stored on private cloud hosted in an ISO 27001 DataCenter located in the European Union and cannot be lawfully accessed or read by unauthorized users. All recorded clinical data are intended for medical and scientific use for the benefit of the patients, the general and the scientific community and health authorities.

The GeroCovid data collection started on April 25 th , 2020. As of September 16 th , 2020, 66 investigational sites have obtained their local Ethical Committee and institutional board approval, while 24 sites are waiting for final approval. A total of 1618 observed cases (mean age 80.6±9.0 years; 45% men) to date have been recorded in the e-Registry. The age distribution of male and female participants recorded in the GeroCovid e-Registry is illustrated in Figure 1 . Of the total cases, 883 (55%) individuals were assessed in the hospital setting (GeroCovid acute wards and outcomes cohorts), 229 (14%) in long-term care facilities (GeroCovid LTCFs cohort), and 506 (31%) in outpatient or home care services (GeroCovid home and outpatients' care, GeroCovid dementiadrug monitoring, and GeroCovid dementiapsychological health) (Figure 2 ). The current average inclusion rate is 11.2 patients/day, and the expected final sample should include about 2000 observed cases. Preliminary results describing the finally included population will be available in November 2020, while results over the complete study duration will be available in January 2021.

The GeroCovid study will contribute to increase knowledge on Covid-19 effects on individuals aged ≥60 years, the most vulnerable to the disease, by providing concrete and useful information to face the ongoing and the future pandemics. The strength of the project is the involvement of multiple centers and settings of care, which will allow exploring the multifaceted impact of Covid-19 pandemia on health status in representative subsets of the geriatric (and pre-geriatric) population. In particular, using high-quality data, the GeroCovid framework will investigate risk factors, clinical presentation and outcomes in Covid-19 inpatients; best strategies to prevent infection in long-term care facilities; impact of Covid-19 and social isolation on emotional, neuropsychologic, functional and physical health; and, possibility of a remote monitoring of drug treatment in dementia.

GeroCovid will provide original information on three main aspects of Covid-19 pandemic, i.e. SARS-CoV-2 infection onset, clinical course of Covid-19, and effects on health status of people in advanced age, including individuals at risk not affected by Covid-19.

As regards the first aspect, i.e. disease onset, the study will help to identify the factors associated with SARS-CoV-2 infection and its heterogeneous presentation. So far, inconsistent data have emerged about symptoms variability in older adults at disease onset [3, 24] . GeroCovid will focus on potentially atypical Covid-19 presentations and on their associated prognostic value. An interesting contribution of GeroCovid will be provided by the involvement of long-term care facilities, which are among the major reservoirs of the frailest older population. The GeroCovid LTCFs cohort will, therefore, give useful insights on the disease onset in such individuals, as well as on the most effective preventive measures to be implemented.

With regard to clinical course, GeroCovid will use multicenter information from three European countries to recognize factors heralding a faster and more severe disease progression. The extraction of data from different geographical contexts, even at the national level, will provide a picture of the various therapeutic approaches adopted in the past months based on local guidelines and resources' availability. Special attention will also be paid to investigate factors influencing the management of the disease, and to evaluate which therapeutic approaches may lead to better outcomes based on individual characteristics.

Finally, GeroCovid assesses the effects of the pandemic on the health of both Covid-19 patients and older people at risk of Covid-19 in specific care settings, considering physical, mental and social well-being, in accordance with the WHO Constitution [25]. This step of the project will provide important insights not only for physicians but also for healthcare systems and societies, which have to address the emerging needs of individuals in the post-acute phase of the disease [26, 27] . Moreover, GeroCovid will focus on the impact of the pandemic on non Covid-19 geriatric patients. Indeed, there is evidence that the pandemic could have affected care pathways, including cognitive status, functional abilities and psychological health of frail older people, with a special focus on dementia. Recently published data suggest that during lock-down a rapid increase of behavioral symptoms and of stress-related symptoms were observed in more than half of dementia patients and caregivers [28] . As social distancing measures are likely to last for several months, due to persistence of pandemics, it is important to quantify these emerging needs and to assess the ability of health services, including remote telemonitoring, to address them. These aspects will be investigated primarily in the GeroCovid home and outpatients' care, GeroCovid dementiadrug treatment, and GeroCovid dementiapsychological health cohorts.

The multi-setting results of GeroCovid will contribute to developing new evidence-based recommendations promoting the prevention and management of Covid-19, and the optimization of care provision for older patients even in such emergency situations. Therefore, the potential impact of the study is not only addressed to the health of individuals, but also to the healthcare system. Indeed, evidence emerged from GeroCovid will improve the clinical management of Covid-19, possibly optimizing resource allocation and increasing readiness of healthcare and public health systems to front possible future pandemics. This will improve the resilience of healthcare systems that, in many cases, demonstrated an insufficient capacity to maintain overall efficiency in response to the current outbreak [27] . In addition, GeroCovid will inform on the burden of the disease that, even in its post-acute phase, may raise new care and assistance needs associated to nonnegligible costs at the familiar, societal, and healthcare system levels. Older adults may be especially vulnerable to the consequences of Covid-19 as a disease that can alter the labile balance between multiple chronic conditions and treatments, with a negative effect on physical, mental, and functional well-being. In this sense, Covid-19 pandemics can be considered as a prototype of a stressful scenario for the frailest individuals, for our societies and healthcare systems. Consequently, information and possible solutions derived from GeroCovid will go beyond the ongoing pandemic and might be applied to future crisis of similar or different nature.

One obstacle that may influence the achievement of the expected goals of GeroCovid concerns the potential heterogeneity of data coming from different settings of care. At this regard, the GeroCovid coordinating group agreed on minimum core information shared by all study cohorts. Another possible limitation of the project is the recruitment limited to people aged 60 years or older, which will not allow GeroCovid to get a complete picture on the risk/protective factors, clinical course and outcomes of Covid-19 across all age groups, from young to older individuals. However, focusing on advanced age, the study will explore a broad set of key aspects of Covid-19 just in the part of the population that has been most burdened by the pandemics.

The multi-setting, multi-purpose and multicentric GeroCovid initiative is a unique opportunity to explore relevant aspects of Covid-19 with high-quality and comprehensive data on the health of individuals aged 60 Literature data: the maximum frequency of atypical Covid-19 symptoms reported by the literature is of 12% [3, 24] .

Sample size computation: under the hypothesis of a frequency of atypical symptoms >20% and considering a power of 80% and alpha = 0.05, the needed sample size was estimated to be at least of 128 patients (precision=7%).

ADL and IADL [30, 31] 

Purposive sample of at least 100 outpatients recently hospitalized for Covid-19.

-ADL and IADL [30, 31] -CIRS [32] -MMSE [35] -mMRC [33] -15-item GDS [34] -SF-36 [36] -STAI-Y [37]

Purposive sample of at least 100 outpatients at risk of Covid-19.

-ADL and IADL [30, 31] -CIRS [32] -MMSE [35] -5-/15-item GDS [34] -EUROQOL-5 [38] GeroCovid dementiadrug monitoring Primary outcome: incidence of adverse events related to chronic treatment with cholinesterase inhibitors and/or antipsychotic.

Sample size computation: under the hypothesis of an incidence of adverse events related to chronic treatment with cholinesterase inhibitors and/or antipsychotic of about 10%, and considering an alpha=0.05, the needed sample size was estimated at least of 138 consecutive dementia outpatients (precision=5%).

-Checklist for therapeutic plan renewal of anti-cholinesterase drugs, memantine and antipsychotics -ADL and IADL [30, 31] -MMSE [35] -15-item GDS [34] -Adherence to prescribed treatment (semiquantitative assessment post-lock-down)

Primary outcome: change in depressive and anxiety symptoms.

Literature data: Estimates on the prevalence of depression and anxiety in the Italian population are of 5.1% and 5.0%, respectively [39] . Chinese data showed a prevalence of depression and anxiety during Covid-19 pandemic of 16.5% and 28.8% [40] .

Sample size computation: Hypothesizing that the prevalence of depression and anxiety disorders in older people could double after the pandemics, and assuming a power of 80% and an alpha=0.05, the estimated sample size includes 240 individuals. Considering a drop-out of 20%, the final sample size should be of at least 290 patients.

-ADL and IADL [30, 31] -CIRS [32] -MMSE [35] -MNA-SF [41] -15-item GDS [34] -UCLA 3-items Loneliness Scale [42] -SIS [43] -COPE [44] ;

-DASS-21 [45] ;

-CBI [46] ;

-PSS [47] -CRIq [48] -NPI [49] GeroCovid long-term care facilities

Purposive sample of at least 100 institutionalized individuals with suspected or confirmed SARS-CoV-2 infection.

-ADL and IADL [30, 31] -CIRS [32] - 

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We are thankful to our colleagues who are collaborating in data collection for their valuable contribution, and to all the study participants. We thank Gilda Borselli for her precious support for the organization of the GeroCovid initiative.

Funding sources: This research did not receive any funding from agencies in the public, commercial, or notfor-profit sectors.

years or older. This project will help to optimize Covid-19 prevention and management, with practical implications for ongoing and possible future pandemics.