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NCT04890600 Clinical Trial

COVID-19 and Psycological Well-being in Healthcare Workers

Distress, Emotional Clinical Trial

— BE-STRONG  

Official title:
Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04890600
Other study ID # RP 20/14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 1, 2021

Study information
Verified date May 2021
Source IRCCS San Raffaele Roma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules. No personal data are required.

Description:

Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19. Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthworkers of San Raffaele Institution - age>18 Exclusion Criteria: - all those who do not agree

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• well-being assessment
exploration of emotional, cognitive and behavioural resources of healthcare professionals

Locations
Country Name City State
Italy IRCCS San Raffaele Roma Rome

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Levels of anxiety and depression Hospital Anxiety and Depression Scale (HADS) Consists of 14 questions, each of which is rated from 0 to 4 according to the severity of the experienced symptoms. 6 months
Primary Coping strategies Brief-COPE Consists of 28 items divided into 14 scales, relating to 14 identified coping strategies. Each item is rated on a 4 points Likert scale. 6 months
Primary Levels of resilience 14-Item Resilience Scale Consists of 14 items, each rated on a 7 levels Likert scale and evaluates the levels of resilience. 6 months
Primary Levels of fear of COVID-19 FEAR OF COVID-19 SCALE Consists of 7 items, each rated on a Likert scale from 1 to 5, with the aim of assessing the levels of fear related to COVID-19 6 months
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