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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035563
Other study ID # COVID0921
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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