NCT04368312

Brief Summary

Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

April 9, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

April 9, 2020

Last Update Submit

May 5, 2021

Conditions

Keywords

quality of lifepsychological distress

Outcome Measures

Primary Outcomes (6)

  • PCL5 Questionnaire

    Validated 20-items questionnaire for PTSD

    14 days

  • BSI - Brief symptom inventory

    The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.

    14 days

  • PHQD

    Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment

    14 days

  • WHO - QoL BREF

    Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems.

    14 days

  • STAXI

    The State-Trait Anger Expression Inventory is used to measure the expressions \& control of anger

    14 days

  • AUDIT questionnaire

    The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption

    14 days

Study Arms (1)

Health care providers/hospital staff

The targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19

Other: No intervention

Interventions

No intervention, just of questionnaire including validated tests

Health care providers/hospital staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion of all persons which can be attributed to hospital stuff, those include doctors and nurses (male/female)

You may qualify if:

  • Hospital staff (doctors and nurses)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

  • Wesemann U, Hadjamu N, Wakili R, Willmund G, Vogel J, Rassaf T, Siebermair J. Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19. Health Equity. 2021 Apr 19;5(1):181-184. doi: 10.1089/heq.2020.0119. eCollection 2021.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 29, 2020

Study Start

May 6, 2020

Primary Completion

September 30, 2020

Study Completion

December 30, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations