COVID-19 Clinical Trial
— PICOVIDSOfficial title:
Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives. An Exploratory 18-month Follow-up Study for COVID-19 ICU Survivors and Their Relatives.
Verified date | April 2022 |
Source | General Hospital Groeninge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. 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. What are important risk factors for these symptoms and disorders? 3. What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Groeninge Kortrijk | Kortrijk |
Lead Sponsor | Collaborator |
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General Hospital Groeninge |
Belgium,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Composite outcome: Prevalence of psychiatric disorders among relatives of COVID ICU survivors. | Assessed during clinical interview. Generalised Anxiety Disorder (GAD) and depression using DSM-5 criteria as assessed in Mini-International Neuropsychiatric Interview (MINI). PTSD as assessed using Clinician Administered PTSD Scale for DSM-5 (CAPS-5). | 18 months after ICU discharge | |
Secondary | Composite outcome: Prevalence of psychiatric disorders among COVID ICU survivors. | Assessed during clinical interview. Generalised Anxiety Disorder (GAD) and depression using DSM-5 criteria as assessed in Mini-International Neuropsychiatric Interview (MINI). PTSD as assessed using Clinician Administered PTSD Scale for DSM-5 (CAPS-5). | 18 months after ICU discharge | |
Secondary | Prevalence of cognitive impairment in COVID-19 ICU survivors and their relatives | Cognitive Failure Questionnaire (CFQ) with score ranging from 0 (no impairment) to 100 (maximum impairment) | 18 months after ICU discharge | |
Secondary | Impact of caring for COVID-19 ICU survivor after hospital discharge on the relative | Caregiver Reaction Assessment (CRA) scale for relatives: multidimensional measure of the reaction of the relative to caring for a COVID-19 ICU survivor after hospital discharge. Evaluation by 5 point Likert scale (ranging from 1 = strongly disagree to 5 = strongly agree). Domains assessed are financial problems, disrupted schedule, lack of family support, health problems and self-esteem. | 18 months after ICU discharge | |
Secondary | Patient and relatives' satisfaction level about continuity of care after hospital discharge | Patient Continuity of Care Questionnaire adjusted (PCCQ) for both patient and relative: total score of the questionnaire ranges from 6 to 30, higher score indicates higher continuity while a score < 24 indicates insufficient continuity. | 18 months after ICU discharge |
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