Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed by China on January 30, 2020. Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with devastating consequences for the health of the population and the economy of our country. As published by the Italian National Institute of Health, the starting date of the symptoms dates back to the end of January, the first case diagnosed dates back to 21 February 2020 while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020, there were 101739 positive subjects and 11591 deaths (Civil Protection data). According to data published by the World Health Organization, most people with COVID-19 develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen therapy and 5% require an ICU admission. The emergency from Covid19 made it necessary to provide institutional social distancing conditions which resulted in rehabilitation departments being prohibited from visiting patients by family members and/or caregivers. This event, although necessary, led to the first moment of discomfort on the part of patients and family members; to overcome this reaction "technological" solutions were found, trying to give continuity to the contact between the patient and the family member through the use of video calls. Despite this, the COVID-19 emergency and the limitations resulting from social distancing likely have an impact on both patients and family members/caregivers that needs to be assessed.
Aims:
The study aims to measure the quality of life (QoL) and the emotional-affective sphere of
patients, currently hospitalized in residential structures, and their family members.
The study data will allow identifying (a) whether the social distancing between family
members/caregivers and patients undergoing rehabilitation for orthopedic or neurological
disabilities affects the quality of life and the emotional-affective sphere and (b) if these
conditions change over time. The data obtained will, therefore, allow identifying those
subjects who present a particular fragility of the emotional-affective sphere and who
therefore need attention and possibly psychological support that will be prescribed.
Procedures:
Demographic (for patients and caregivers) and anamnestic (only for patients) data will be
collected; moreover, disability will be assessed in patients using the modified Barthel
index.
Three questionnaires will be administered to patients and caregivers:
- The Short Form (36) Health Survey (SF36), to evaluate the QoL;
- The Beck Anxiety Inventory (BAI), to evaluate the emotional state;
- The Beck Depression Inventory-II (BDI-II), to evaluate mood.
These questionnaires will be administered after one month of hospitalization (T0), and after
one (T1) and two (T2) months after T0. Finally, at time T1 and T2 it will be registered if
the patient is still hospitalized or discharged (and in the latter case the days between the
discharge and the compilation of the questionnaire will be recorded). Since the three
selected questionnaires provide for self-administration, to simplify the collection of data
relating to caregivers, the implementation and use of an online questionnaire will be
assessed. This questionnaire will also provide for the collection of consent to the use of
data by the subject and will guarantee their privacy.
Inclusion Criteria:
- patients admitted to the centers of the Don Gnocchi Foundation participating in the
study and their caregivers will be recruited
Exclusion Criteria:
- For patients: a score on the Mini-Mental State Examination (MMSE) scale lower than 24
which prevents the administration of SF36;
- For patients and caregivers: failure to acquire informed consent
Don Gnocchi Foundation
Rome, Italy
Irene APRILE, MD,PHD, Principal Investigator
IRCCS Fondazione Don Carlo Gnocchi