Impact of a Communication Strategy in the Prevention of Depressive Symptoms in Patients with Covid-19

Not Applicable

Completed

• Conditions: Covid19; Critical Illness; Mechanical Ventilation
• Interventions: Behavioral: Intervention. Early and integral communication strategy (EICS)

• Registration Number: NCT05035563
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-27
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Primary Completion: 2022-03-01
• Study Completion: 2022-07-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Early and integral communication strategy (EICS) (Post-intervention)	Intervention. Early and integral communication strategy (EICS)	EICS that includes a bundle of various strategies that allow to favor communication and contact between family members, patients and health team. That considers the delivery of: (1) Receive timely and understandable information; (2) Receive visits, companionship, and spiritual assistance

Primary Outcome Measures

Name	Time	Method
Rate of depressive symptoms	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 Outcome Measures

Name	Time	Method
Risk factors of depressive symptoms	Third month post-discharge from ICU	Identify risk factors associated with depressive symptoms at 3 months post ICU in patients with severe Covid-19, their relatives and health team. Considering physical health, mental health and sociodemographic factors.; To measure depressive symptoms will be used Hospital Anxiety and Depression Scale (HADS), total scores for depression range from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14) or severe (15-21)
Cognition status post-ICU	Twelfth month post-discharge from ICU	MOCA blind instrument will be applied to patients.
ICU memories post ICU	Twelfth month post-discharge from ICU	ICU Memory Tool (ICUMT) will be applied to patients.In ICUMT, memories are categorized in subscales of factual memories, memories of feelings, and memories of delusion
Functional independence post-ICU	Twelfth month post-discharge from ICU	Barthel will be used in patients
Post traumatic stress post-ICU	Twelfth month post-discharge from ICU	This mental health condition will be evaluated in patients, family members and the health team, with the instrument Impact of Event Scale Revised (IES-R).
Functionality Status post-ICU	Twelfth month post-discharge from ICU	Post-COVID-19 Functional Status (PCFS) will be used in patients
Anxiety post ICU	Twelfth month post-discharge from ICU	This mental health condition will be evaluated in patients, family members and the health team
Quality of life post ICU	Twelfth month post-discharge from ICU	Euro Qol (EQ-5D) will be applied to patients.
Rate of depressive symptoms	Twelfth 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)

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile - Medicina; 🇨🇱 Santiago, Metropolitana, Chile