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

Primary Purpose

Critical Illness, Mechanical Ventilation, Covid19

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Intervention. Early and integral communication strategy (EICS)
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring COVID-19, Depression post-ICU, Non-pharmacological intervention, Communication strategy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontificia Universidad Católica de Chile - Medicina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional communication management (Pre-intervention)

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

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
Functional independence post-ICU
Barthel will be used in patients
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
Functionality Status post-ICU
Post-COVID-19 Functional Status (PCFS) will be used in patients
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
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).
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
Cognition status post-ICU
MOCA blind instrument will be applied to patients.
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
Quality of life post ICU
Euro Qol (EQ-5D) will be applied to patients.
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
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
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)
Anxiety post ICU
This mental health condition will be evaluated in patients, family members and the health team
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)

Full Information

First Posted
March 27, 2021
Last Updated
April 3, 2023
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
University of Chile, Universidad de La Frontera
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1. Study Identification

Unique Protocol Identification Number
NCT05035563
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
University of Chile, Universidad de La Frontera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation, Covid19
Keywords
COVID-19, Depression post-ICU, Non-pharmacological intervention, Communication strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional communication management (Pre-intervention)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Early and integral communication strategy (EICS) (Post-intervention)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Intervention. Early and integral communication strategy (EICS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of depressive symptoms
Description
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)
Time Frame
Third month post-discharge from ICU
Secondary Outcome Measure Information:
Title
Risk factors of depressive symptoms
Description
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)
Time Frame
Third month post-discharge from ICU
Title
Functional independence post-ICU
Description
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
Time Frame
Third month post-discharge from ICU
Title
Functional independence post-ICU
Description
Barthel will be used in patients
Time Frame
Twelfth month post-discharge from ICU
Title
Functionality Status post-ICU
Description
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
Time Frame
Third month post-discharge from ICU
Title
Functionality Status post-ICU
Description
Post-COVID-19 Functional Status (PCFS) will be used in patients
Time Frame
Twelfth month post-discharge from ICU
Title
Post traumatic stress post-ICU
Description
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
Time Frame
Third month post-discharge from ICU
Title
Post traumatic stress post-ICU
Description
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).
Time Frame
Twelfth month post-discharge from ICU
Title
Cognition status post-ICU
Description
MOCA blind instrument will be applied to patients. The total possible score is 22 points; a score of 18 or above is considered normal
Time Frame
Third month post-discharge from ICU
Title
Cognition status post-ICU
Description
MOCA blind instrument will be applied to patients.
Time Frame
Twelfth month post-discharge from ICU
Title
Quality of life post ICU
Description
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
Time Frame
Third month post-discharge from ICU
Title
Quality of life post ICU
Description
Euro Qol (EQ-5D) will be applied to patients.
Time Frame
Twelfth month post-discharge from ICU
Title
ICU memories post ICU
Description
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
Time Frame
Third month post-discharge from ICU
Title
ICU memories post ICU
Description
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
Time Frame
Twelfth month post-discharge from ICU
Title
Anxiety post ICU
Description
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)
Time Frame
Third month post-discharge from ICU
Title
Anxiety post ICU
Description
This mental health condition will be evaluated in patients, family members and the health team
Time Frame
Twelfth month post-discharge from ICU
Title
Rate of depressive symptoms
Description
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)
Time Frame
Twelfth month post-discharge from ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla Alegria
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidad Católica de Chile - Medicina
City
Santiago
State/Province
Metropolitana
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

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

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