NCT04890600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
Last Updated

April 10, 2024

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

April 22, 2021

Last Update Submit

April 9, 2024

Conditions

Distress, EmotionalCoping Behavior

Keywords

COVID-19, resilience, depression, healthcare workers

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Interventions

well-being assessmentBEHAVIORAL

exploration of emotional, cognitive and behavioural resources of healthcare professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nurses, medical doctors, therapists, researchers, administrative workers

You may qualify if:

  • Healthworkers of San Raffaele Institution
  • age\>18

You may not qualify if:

  • all those who do not agree

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Roma

Rome, 00166, Italy

Location

MeSH Terms

Conditions

COVID-19Depression

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Study Officials

  • Stefano Bonassi, PhD

    IRCCS San Raffaele Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 18, 2021

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 10, 2024

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)