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

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

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)

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Pontificia Universidad Católica de Chile - Medicina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Traditional communication management (Pre-intervention); Traditional communication practices are maintained, which consists of reporting the patient's medical conditions or specific requirements of the case, between the health team and the family. According to the social and administrative conditions of each centers, medical telephone information is provided on the conditions of the patients.
Experimental: Early and integral communication strategy (EICS) (Post-intervention); 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	Behavioral: Intervention. Early and integral communication strategy (EICS); This intervention will be implemented in patients since they are hospitalized in the ICU where is expected: Facilitate contact and communication between patients, families and the health team.; Respond to the communication needs of family members.; Reduce equipment overload and facilitate communication with families and patients, providing tools and timely support.; Build a positive and trusting relationship of relatives and patients with health teams. The intervention considers the following actions: - Training in communication to the health team; - Written material; - Family website; - Standardized and daily telephone information; - Health Team Support Strategy; - Weekly multidisciplinary virtual meeting with the family; - ICU diaries for family members

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of depressive symptoms	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)	Third month post-discharge from ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of depressive symptoms	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)	Third month post-discharge from ICU
Functional independence post-ICU	Barthel will be used in patients, the score are ordered: 0-20 suggests total dependence, 21-60 severe dependence, 61-90 moderate dependence and 91-99 slight dependence, 100 independence	Third month post-discharge from ICU
Functional independence post-ICU	Barthel will be used in patients	Twelfth month post-discharge from ICU
Functionality Status post-ICU	Post-COVID-19 Functional Status (PCFS) will be used in patients, the score are : 0 = No functional limitations, 1=Negligible functional limitations, 2=Slight functional limitations, 3=Moderate functional limitations,4=Severe functional limitations, 5=death	Third month post-discharge from ICU
Functionality Status post-ICU	Post-COVID-19 Functional Status (PCFS) will be used in patients	Twelfth month post-discharge from ICU
Post traumatic stress post-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). Score Interpretation: 24-32: PTSD is a clinical concern, 33-38: This represents the best cutoff for a probable diagnosis of PTSD, 39 and above: This is high enough to suppress your immune system's functioning	Third month post-discharge from ICU
Post traumatic stress post-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).	Twelfth month post-discharge from ICU
Cognition status post-ICU	MOCA blind instrument will be applied to patients. The total possible score is 22 points; a score of 18 or above is considered normal	Third month post-discharge from ICU
Cognition status post-ICU	MOCA blind instrument will be applied to patients.	Twelfth month post-discharge from ICU
Quality of life post ICU	Euro Qol (EQ-5D) will be applied to patients. An EQ-5D summary index is derived by applying a formula that essentially attaches values (weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1, the value for full health	Third month post-discharge from ICU
Quality of life post ICU	Euro Qol (EQ-5D) will be applied to patients.	Twelfth month post-discharge from ICU
ICU memories post 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	Third month post-discharge from ICU
ICU memories post 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	Twelfth month post-discharge from ICU
Anxiety post ICU	This mental health condition will be evaluated in patients, family members and the health team, with the instrument HADS total scores for anxiety range from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14) or severe (15-21)	Third month post-discharge from ICU
Anxiety post ICU	This mental health condition will be evaluated in patients, family members and the health team	Twelfth month post-discharge from ICU
Rate of depressive symptoms	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)	Twelfth month post-discharge from ICU

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: University of Chile; Universidad de La Frontera
• Investigators: Principal Investigator: Leyla Alegria, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: March 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Non-pharmacological intervention; Depression post-ICU; Communication strategy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Behavioral Symptoms; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Depression; Critical Illness
• Other Study ID Numbers: COVID0921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No