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

NCT05035563 | Completed DMC

• 1 other identifier: COVID0921
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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)

Conditions

Critical Illness; Mechanical Ventilation; Covid19

Keywords

COVID-19; Depression post-ICU; Non-pharmacological intervention; Communication strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Risk factors of depressive symptoms

  Third month post-discharge from ICU

• Functional independence post-ICU

  Third month post-discharge from ICU

• Functional independence post-ICU

  Twelfth month post-discharge from ICU

• Functionality Status post-ICU

  Third month post-discharge from ICU

• Functionality Status post-ICU

  Twelfth month post-discharge from ICU

Study Arms (2)

Traditional communication management (Pre-intervention)

NO 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.

Early and integral communication strategy (EICS) (Post-intervention)

EXPERIMENTAL

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)

Interventions

Intervention. Early and integral communication strategy (EICS) BEHAVIORAL

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: 1. \- Training in communication to the health team 2. \- Written material 3. \- Family website 4. \- Standardized and daily telephone information 5. \- Health Team Support Strategy 6. \- Weekly multidisciplinary virtual meeting with the family 7. \- ICU diaries for family members

Early and integral communication strategy (EICS) (Post-intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University of Chile: collaborator
• Universidad de La Frontera: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile - Medicina

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Critical Illness; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Leyla Alegria

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: September 5, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 13, 2025

Record last verified: 2021-03

Locations

CL (1)