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Completed

NCT Number: NCT05035563

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

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)

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Key information

Conditions

Critical Illness COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Disease Attributes Infections Lung Diseases Mechanical Ventilation Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Católica de Chile - Medicina

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention. Early and integral communication strategy (EICS)

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:

  • - 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 outcomes

  1. 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)

Secondary outcomes

  1. Risk factors of depressive symptoms

    Time frame: Third month post-discharge from ICU

    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)

  2. Functional independence post-ICU

    Time frame: Third month post-discharge from 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

  3. Functional independence post-ICU

    Time frame: Twelfth month post-discharge from ICU

    Barthel will be used in patients

  4. Functionality Status post-ICU

    Time frame: Third month post-discharge from 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

  5. Functionality Status post-ICU

    Time frame: Twelfth month post-discharge from ICU

    Post-COVID-19 Functional Status (PCFS) will be used in patients

  6. Post traumatic stress post-ICU

    Time frame: Third month post-discharge from 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

  7. Post traumatic stress post-ICU

    Time frame: Twelfth month post-discharge from 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).

  8. Cognition status post-ICU

    Time frame: Third month post-discharge from 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

  9. Cognition status post-ICU

    Time frame: Twelfth month post-discharge from ICU

    MOCA blind instrument will be applied to patients.

  10. Quality of life post ICU

    Time frame: Third month post-discharge from 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

  11. Quality of life post ICU

    Time frame: Twelfth month post-discharge from ICU

    Euro Qol (EQ-5D) will be applied to patients.

  12. ICU memories post ICU

    Time frame: Third month post-discharge from 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

  13. ICU memories post ICU

    Time frame: Twelfth month post-discharge from 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

  14. Anxiety post ICU

    Time frame: Third month post-discharge from 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)

  15. Anxiety post ICU

    Time frame: Twelfth month post-discharge from ICU

    This mental health condition will be evaluated in patients, family members and the health team

  16. Rate of depressive symptoms

    Time frame: Twelfth 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)

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Universidad de La Frontera
  • University of Chile

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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