Clinical trial NCT04408196: QoL and the Emotional-affective Sphere in Rehabilitation Setting During COVID-19 Quarantine
Official title: Effects of Social Distancing on the Quality of Life and on the Emotional-affective Sphere of Caregivers and Patients Hospitalized in Residential Rehabilitation Departments: an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rehabilitation
Keywords: rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to inpatients rehabilitation centers

Caregivers of patients admitted to inpatients rehabilitation centers

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form-36 Health Survey (SF36)
timeFrame: After one month of hospitalisation (baseline, T0)
measure: Short Form (36) Health Survey (SF36)
timeFrame: One month after baseline (T1)
measure: Short Form (36) Health Survey (SF36)
timeFrame: Two months after baseline (T2)
measure: Beck Anxiety Inventory (BAI)
timeFrame: After one month of hospitalisation (baseline,T0)
measure: Beck Anxiety Inventory (BAI)
timeFrame: One month after baseline (T1)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Two months after baseline (T2)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: After one month of hospitalisation (baseline)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: One month after baseline (T1)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Two months after baseline (T2)
Secondary outcomes:
measure: modified Barthel Index (mBI)
timeFrame: After one month of hospitalisation (baseline, T0)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Don Gnocchi Foundation
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Irene APRILE, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
citation: Aprile I, Piazzini DB, Bertolini C, Caliandro P, Pazzaglia C, Tonali P, Padua L. Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation. Neurol Sci. 2006 Apr;27(1):40-6. doi: 10.1007/s10072-006-0563-5.