Clinical trial NCT05035563: Impact of a Communication Strategy in the Prevention of Depressive Symptoms in Patients with Covid-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation
Covid19
Keywords: COVID-19
Depression post-ICU
Non-pharmacological intervention
Communication strategy
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: University of Chile
name: Universidad de La Frontera
First posted: 2021-09-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre-intervention: The practices of each ICU will be maintained, until the moment that according to randomization corresponds to the beginning of the intervention, in each center

Post-intervention: Integral and early strategy to facilitate communication between the family, patient and health team. For this it will be implemented written material, via the web (tablet and webmaster) and by telephone.

It also includes strategies to support health teams, weekly multidisciplinary virtual meetings with the family, ICU diaries for family members.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of depressive symptoms
timeFrame: Third month post-discharge from ICU
Secondary outcomes:
measure: Risk factors of depressive symptoms
timeFrame: Third month post-discharge from ICU
measure: Functional independence post-ICU
timeFrame: Third month post-discharge from ICU
measure: Functional independence post-ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Functionality Status post-ICU
timeFrame: Third month post-discharge from ICU
measure: Functionality Status post-ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Post traumatic stress post-ICU
timeFrame: Third month post-discharge from ICU
measure: Post traumatic stress post-ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Cognition status post-ICU
timeFrame: Third month post-discharge from ICU
measure: Cognition status post-ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Quality of life post ICU
timeFrame: Third month post-discharge from ICU
measure: Quality of life post ICU
timeFrame: Twelfth month post-discharge from ICU
measure: ICU memories post ICU
timeFrame: Third month post-discharge from ICU
measure: ICU memories post ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Anxiety post ICU
timeFrame: Third month post-discharge from ICU
measure: Anxiety post ICU
timeFrame: Twelfth month post-discharge from ICU
measure: Rate of depressive symptoms
timeFrame: Twelfth month post-discharge from ICU
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile - Medicina
state: Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Leyla Alegria
role: PRINCIPAL_INVESTIGATOR
References: