Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives

NCT05348720 | Unknown

• 1 other identifier: AZGS2021059
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

As ICU mortality has been significantly decreased over the last two decades, the focus has been shifting from short term (such as ICU and hospital mortality) to long-term outcome. This evolution has led to a new entity that has been established in 2012 at a stakeholder conference: the Post-Intensive Care Syndrome (PICS). It is defined as impairments in physical, cognitive and mental health status arising after critical illness and persisting beyond acute care hospitalisation. As family members of ICU patients may also be affected by mental health impairment, the PICS-F (F for Family) has been introduced simultaneously. It is expected that the COVID-19 pandemic will result in a significant increase of the proportion of patients and relatives suffering PICS and PICS-F, as there is during the COVID-19 related ICU-stay exposure to a high number of risk factors for developing these entities. This Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study that aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge. Specific research questions are:

1. 1.What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge?
2. 2.What are important risk factors for these symptoms and disorders?
3. 3.What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?

Conditions

Post Intensive Care Syndrome; PICS; COVID-19; Critically Ill; Mental Health

Keywords

COVID-19; ICU survivor; PICS; PICS-F; neurocognitive sequels; Follow-up

Outcome Measures

Primary Outcomes (2)

• Composite outcome: Prevalence of psychiatric symptoms in COVID-19 ICU survivors

  symptoms of anxiety(1), depression(2) and PTSD(3) (1+2) anxiety and depression measured using the HADS symptom score (score range 0 (best) to 42 (worst)): presence of symptoms of anxiety if HADS anxiety subscale \> 7; presence of symptoms of depression if HADS depression subscale \> 8; (3) presence of PTSD-related symptoms measured using the PCL-5 COVID score (score range 17 (not all PTSD) to 85(most extreme form of PTSD): PTSD symptoms if score \> 32.

  18 months after ICU discharge

• Composite outcome: Prevalence of psychiatric symptoms among relatives of COVID-19 ICU survivors

  symptoms of anxiety(1), depression(2) and PTSD(3) (1+2) anxiety and depression measured using the HADS symptom score (score range 0 (best) to 42 (worst)): presence of symptoms of anxiety if HADS anxiety subscale \> 7; presence of symptoms of depression if HADS depression subscale \> 8; (3) presence of PTSD-related symptoms measured using the PCL-5 COVID score (score range 17 (not all PTSD) to 85(most extreme form of PTSD): PTSD symptoms if score \> 32.

  18 months after ICU discharge

Secondary Outcomes (5)

• Composite outcome: Prevalence of psychiatric disorders among relatives of COVID ICU survivors.

  18 months after ICU discharge

• Composite outcome: Prevalence of psychiatric disorders among COVID ICU survivors.

  18 months after ICU discharge

• Prevalence of cognitive impairment in COVID-19 ICU survivors and their relatives

  18 months after ICU discharge

• Impact of caring for COVID-19 ICU survivor after hospital discharge on the relative

  18 months after ICU discharge

• Patient and relatives' satisfaction level about continuity of care after hospital discharge

  18 months after ICU discharge

Study Arms (2)

COVID-19 ICU survivor

COVID-19 patients admitted to ICU between the 1st of March 2020 and the 30rd of May 2021, who survived ICU stay and still alive 18 months after ICU discharge.

Relatives

Relative of those COVID-19 patients enrolled in the 'COVID-19 ICU survivor' cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All COVID-19 patients admitted to the ICU between 1/3/2020 and 31/5/2021, who survived the ICU and index hospitalisation, requiring High Flow Oxygen Therapy (HFOT), non-invasive ventilation (NIV) or mechanical ventilation (MV) due to respiratory failure primarily related to COVID-19, will be eligible. Covid-19 diagnosis will be based on RNA detection of SARS-COV-2 using RT-PCR of a nasopharyngeal swab or through respiratory specimen obtained by bronchoscopy. All eligible patients, still alive 18 months after ICU discharge, will be contacted by telephone for participation in this study. Simultaneously, these patients will be asked if their family member is keen to participate in the study as well. We aim to enroll the family member the most involved in the patient's ICU stay.

You may qualify if:

• COVID-19 patient admitted to the ICU between 1st of March 2020 and 31st of May 2021
• Surviving ICU and index hospitalisation
• Respiratory failure due to COVID-19 with need for High Flow Oxygen Therapy (HFOT), non-invasive ventilation (NIV) or mechanical ventilation (MV)
• Family member (caregiver) of eligible COVID-19
• Written informed consent obtained from patient and family member

You may not qualify if:

• ICU length of stay (ICU-LOS) \</= 72h
• Decease of the COVID-19 patient during 18-month follow-up period
• Respiratory failure and admission to ICU was not primary related to COVID-19
• Poor or moderate knowledge of Dutch, French or English language
• Mentally not able to complete questionnaires or to give informed consent, due to a neurocognitive deficit

Sponsors & Collaborators

• General Hospital Groeninge: lead

Study Sites (1)

AZ Groeninge Kortrijk

Kortrijk, 8500, Belgium

Location

Related Publications (16)

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MeSH Terms

Conditions

postintensive care syndrome; COVID-19; Critical Illness; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Stoffel Lamote, MD

  General Hospital Groeninge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Intensive Care Unit

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 27, 2022
• Study Start: March 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

BE (1)