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Clinical Trials/NCT05035563
NCT05035563
Completed
Not Applicable

Impact of an Early and Comprehensive Communication Strategy in the Prevention of Depressive Symptoms in Patients with Severe Covid-19, Their Families and Health Personnel

Pontificia Universidad Catolica de Chile1 site in 1 country350 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Pontificia Universidad Catolica de Chile
Enrollment
350
Locations
1
Primary Endpoint
Rate of depressive symptoms
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to compare the effect of an early and integral communication strategy (EICS) versus standard care, on the rate of depressive symptoms at 3 months after discharge from the ICU, in patients with severe Covid-19, their family members and health personnel.

Evaluating the rate of depressive symptoms at 3 months after discharge from the ICU, with a) Hospital Anxiety and Depression, b) Posttraumatic Stress Disorder Checklist (S)

Detailed Description

We designed a pre-post intervention study, the groups were non-randomly allocated. The study is implementation in 10 Chilean hospitals, admitting 350 patients. Pre-intervention: The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center. Post-intervention: EICS to facilitate communication between the family, patient and health team, through written material, via the web (tablet and webmaster) and by telephone.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
July 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults\> 18 years old
  • Admitted to the ICU
  • Requiring Mechanical Ventilation\> 12 hrs due to COVID-19

Exclusion Criteria

  • Patients with therapeutic proportionality is defined early
  • Patients with communication limitations (they do not speak Spanish) are excluded.

Outcomes

Primary Outcomes

Rate of depressive symptoms

Time Frame: Third month post-discharge from ICU

The rate of depressive symptoms after discharge from the ICU will be evaluated in patients with severe Covid-19, their relatives and health personnel with the instrument HADS (Hospital Anxiety and Depression Scale)

Secondary Outcomes

  • Risk factors of depressive symptoms(Third month post-discharge from ICU)
  • Cognition status post-ICU(Twelfth month post-discharge from ICU)
  • ICU memories post ICU(Twelfth month post-discharge from ICU)
  • Functional independence post-ICU(Twelfth month post-discharge from ICU)
  • Post traumatic stress post-ICU(Twelfth month post-discharge from ICU)
  • Functionality Status post-ICU(Twelfth month post-discharge from ICU)
  • Anxiety post ICU(Twelfth month post-discharge from ICU)
  • Quality of life post ICU(Twelfth month post-discharge from ICU)
  • Rate of depressive symptoms(Twelfth month post-discharge from ICU)

Study Sites (1)

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