Critical IllnessNCT05035563
Impact of a Communication Strategy in the Prevention of Depressive Symptoms in Patients with Covid-19
A study testing Intervention. Early and integral communication strategy (EICS) in people with Critical Illness and Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation, Covid19
- What is being tested?
- Intervention. Early and integral communication strategy (EICS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults> 18 years old
- Admitted to the ICU
- Requiring Mechanical Ventilation> 12 hrs due to COVID-19
Who cannot join
- Patients with therapeutic proportionality is defined early
- Patients with communication limitations (they do not speak Spanish) are excluded.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile - Medicina
Santiago, Santiago Metropolitan
About this study
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
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)
Read the 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
- Being tested
- Intervention. Early and integral communication strategy (EICS)
- Keywords
- COVID-19, Depression post-ICU, Non-pharmacological intervention, Communication strategy
- Medical subject headings
- Critical Illness, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention. Early and integral communication strategy (EICS)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention. Early and integral communication strategy (EICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Third month post-discharge from ICU
Secondary outcomes (16)
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)
Measured: Third month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
Functional independence post-ICU
Barthel will be used in patients
Measured: Twelfth month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
Functionality Status post-ICU
Post-COVID-19 Functional Status (PCFS) will be used in patients
Measured: Twelfth month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
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).
Measured: Twelfth month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
Cognition status post-ICU
MOCA blind instrument will be applied to patients.
Measured: Twelfth month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
Quality of life post ICU
Euro Qol (EQ-5D) will be applied to patients.
Measured: Twelfth month post-discharge from ICU
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
Measured: Third month post-discharge from ICU
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
Measured: Twelfth month post-discharge from ICU
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)
Measured: Third month post-discharge from ICU
Anxiety post ICU
This mental health condition will be evaluated in patients, family members and the health team
Measured: Twelfth month post-discharge from ICU
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)
Measured: Twelfth month post-discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jun 2021
- Primary completion1 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, Universidad de La Frontera
- Responsible party
- Sponsor
- Investigators
- Leyla Alegria, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035563
- Sponsor's protocol ID
- COVID0921
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05035563
- Acronym / sponsor ID
- COVID0921
- Conditions
- Critical Illness, Mechanical Ventilation, Covid19
- Keywords
- COVID-19, Depression post-ICU, Non-pharmacological intervention, Communication strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- University of Chile, Universidad de La Frontera
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intervention. Early and integral communication strategy (EICS)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults> 18 years old
- Admitted to the ICU
- Requiring Mechanical Ventilation> 12 hrs due to COVID-19
Key exclusion criteria (2 listed)
- Patients with therapeutic proportionality is defined early
- Patients with communication limitations (they do not speak Spanish) are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Early and integral communication strategy (EICS) (Post-intervention) |
Primary outcome
Rate of depressive symptoms
Time frame: Third month post-discharge from ICU
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)
16 secondary outcomes
Risk factors of depressive symptoms
Time frame: Third month post-discharge from ICU
Functional independence post-ICU
Time frame: Third month post-discharge from ICU
Functional independence post-ICU
Time frame: Twelfth month post-discharge from ICU
Functionality Status post-ICU
Time frame: Third month post-discharge from ICU
Functionality Status post-ICU
Time frame: Twelfth month post-discharge from ICU
Post traumatic stress post-ICU
Time frame: Third month post-discharge from ICU
Post traumatic stress post-ICU
Time frame: Twelfth month post-discharge from ICU
Cognition status post-ICU
Time frame: Third month post-discharge from ICU
Cognition status post-ICU
Time frame: Twelfth month post-discharge from ICU
Quality of life post ICU
Time frame: Third month post-discharge from ICU
Quality of life post ICU
Time frame: Twelfth month post-discharge from ICU
ICU memories post ICU
Time frame: Third month post-discharge from ICU
ICU memories post ICU
Time frame: Twelfth month post-discharge from ICU
Anxiety post ICU
Time frame: Third month post-discharge from ICU
Anxiety post ICU
Time frame: Twelfth month post-discharge from ICU
Rate of depressive symptoms
Time frame: Twelfth month post-discharge from ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Alegria principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention. Early and integral communication strategy (EICS) in people with Critical Illness and Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of depressive symptoms (time frame: Third month post-discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.