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

NCT ID: NCT05035563

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-07-01

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.

Conditions

Critical Illness; Mechanical Ventilation; Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Intervention. Early and integral communication strategy (EICS)

Intervention Type: 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

Interventions

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:

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: collaborator

Universidad de La Frontera

OTHER

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leyla Alegria

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Pontificia Universidad Católica de Chile - Medicina

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

COVID0921

Identifier Type: -

Identifier Source: org_study_id