QoL and the Emotional-affective Sphere in Rehabilitation Setting During COVID-19 Quarantine

NCT04408196 | Completed

• 1 other identifier: FDG_socialdistancing_COVID-19
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (9)

• Short Form-36 Health Survey (SF36)

  It is a questionnaire to evaluate the Quality of Life

  After one month of hospitalisation (baseline, T0)

• Short Form (36) Health Survey (SF36)

  It is a questionnaire to evaluate the Quality of Life

  One month after baseline (T1)

• Short Form (36) Health Survey (SF36)

  It is a questionnaire to evaluate the Quality of Life

  Two months after baseline (T2)

• Beck Anxiety Inventory (BAI)

  It is a brief, criteria-referenced assessment for measuring anxiety severity and level

  After one month of hospitalisation (baseline,T0)

• Beck Anxiety Inventory (BAI)

  It is a brief, criteria-referenced assessment for measuring anxiety severity and level

  One month after baseline (T1)

• Beck Anxiety Inventory (BAI)

  It is a brief, criteria-referenced assessment for measuring anxiety severity and level

  Two months after baseline (T2)

• Beck Depression Inventory-II (BDI-II)

  It is a brief, criteria-referenced assessment for measuring depression severity

  After one month of hospitalisation (baseline)

• Beck Depression Inventory-II (BDI-II)

  It is a brief, criteria-referenced assessment for measuring depression severity

  One month after baseline (T1)

• Beck Depression Inventory-II (BDI-II)

  It is a brief, criteria-referenced assessment for measuring depression severity

  Two months after baseline (T2)

Secondary Outcomes (1)

• modified Barthel Index (mBI)

  After one month of hospitalisation (baseline, T0)

Study Arms (2)

Patients

100 patients admitted to an inpatient rehabilitation facility

Caregivers

100 caregivers of patients admitted to an inpatient rehabilitation facility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to inpatients rehabilitation centers Caregivers of patients admitted to inpatients rehabilitation centers

You may qualify if:

• patients admitted to the centers of the Don Gnocchi Foundation participating in the study and their caregivers will be recruited

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Rome, 00168, Italy

Location

Related Publications (2)

• 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.

  PMID: 9817120 BACKGROUND

• 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.

  PMID: 16688598 BACKGROUND

Study Officials

• Irene APRILE, MD,PHD

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD, Principal Investigator, Head of Rehabilitation Unit

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 29, 2020
• Study Start: May 26, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 22, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)