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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035563
• Other study ID #: COVID0921
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Depression
• Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile - Medicina	Santiago	Metropolitana

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Universidad de La Frontera, University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Functional independence post-ICU	Barthel will be used in patients	Twelfth month post-discharge from ICU
Secondary	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
Secondary	Functionality Status post-ICU	Post-COVID-19 Functional Status (PCFS) will be used in patients	Twelfth month post-discharge from ICU
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognition status post-ICU	MOCA blind instrument will be applied to patients.	Twelfth month post-discharge from ICU
Secondary	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
Secondary	Quality of life post ICU	Euro Qol (EQ-5D) will be applied to patients.	Twelfth month post-discharge from ICU
Secondary	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
Secondary	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
Secondary	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
Secondary	Anxiety post ICU	This mental health condition will be evaluated in patients, family members and the health team	Twelfth month post-discharge from ICU
Secondary	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