Post Intensive Care SyndromePICOVIDSNCT05348720
Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives
An observational study of Post Intensive Care Syndrome and PICS, run by General Hospital Groeninge at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome, PICS, COVID-19
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2020to 31 Mar 2023
- Phase
- Observational
- 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
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read more
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:
- 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?
- What are important risk factors for these symptoms and disorders?
- What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
Read the detailed description
Design:
The Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study in a non-university hospital with 31 ICU beds.
Objective:
The study 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:
- 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?
- What are important risk factors for these symptoms and these disorders?
- What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
Patients' recruitment (See section 'inclusion and exclusion criteria' for further details):
Patients admitted to the ICU between 1 March 2020 and 31 May 2021, with respiratory failure primarily due to COVID-19, who survived ICU stay and hospitalisation are eligible and will be contacted by telephone 16 to 18 months after ICU discharge by the research team. Patients will receive information regarding the aim, content and relevance of the study and asked for participation to this study. They will be asked as well whether his or her caregiver the most involved during the ICU stay would participate to the study.
Methods:
Once oral informed consent by telephone will be given, a bundle will be sent to patient and involved relative by post. This bundle contains informed consent, information brochure and several questionnaires.
Questionnaires for patients are:
- Hospital and Depression Scale (HADS anxiety and depression)
- Patient Checklist for DSM-5 (PCL-5) for COVID
- Cognitive Failure Questionnaire (CFQ)
- Short Form 36 Health Survey Questionnaire (SF-36)
- Questionnaire for persistent physical complaints
- Rockwood Clinical Frailty Scale
- Patient Continuity of Care Questionnaire adjusted (PCCQ): subscales relationship in hospital, information transfer)
- Socio-demographic questionnaire
Caregivers will receive the same questionnaires except for the SF-36, the questionnaire assessing persistent physical complaints and the Rockwood Clinical Frailty Scale as these one are not applicable to them, while a Caregiver Reaction Assessment (CRA) scale questionnaire will be added for this cohort.
Consequently psychological, cognitive and physical symptoms, clinical frailty, satisfaction level about care and socio-demographic factors will be assessed.
There are Dutch, French and English versions of this bundle available, as preferred by patient and relative.
Patient and caregiver will be contacted a second time by telephone 10 to 14 days after the first call for verifying whether there are remaining questions after receiving the bundle. A second bundle will be sent by post in case of the first one would have been lost or patient and/or caregiver couldn't be reached.
Questionnaires will be analysed by two members of the research team. Patients and caregivers scoring more than 7 on the HADS-Anxiety, more than 8 on the HADS-Depression or more than 32 on the PCL-5 COVID questionnaire will be considered as having symptoms of respectively anxiety, depression and PTSD. Subsequently, they will be invited for a clinical and structured interview, using the Mini-International Neuropsychiatric Interview (MINI), the Clinician-Administered PTSD scale (CAPS) and the Montreal cognitive Assessment (MoCa). A psychiatrist and clinical psychologist will conduct this interview. Consequently, diagnosis of Generalised Anxiety Disorder (GAD), Depression and PTSD according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as well as cognitive impairment could be established.
Data Collection:
On the one hand, anonymised patient data with respect to the ICU hospitalisation will be collected from patient records (electronic patient records, Patient Data Management System (PDMS), Klinisch Werkstation (KWS), Cyberlab). This data collecting process will be facilitated by LynxCare® company, an Artificial Intelligence (AI) and Natural Language Processing (NLP) based big data platform. This medical data will include: demographics, pre-existing co-morbidities (including Clinical Frailty score (CFS) and Charlson Comorbidity Index, severity of illness scores (APACHE-II score, Simplified Acute Physiology Score (SAPS), Sequential Organ Failure Assessment (SOFA)), specific COVID-treatment, method of respiratory support during ICU stay (High Flow Oxygen, Non-Invasive Ventilation, Mechanical Ventilation, prone ventilation, Extracorporeal Membrane Oxygenation (ECMO), duration of mechanical ventilation, duration of ECMO run, diagnosis of ICU-Acquired Weakness (ICU-AW) or Critical Illness Polyneuropathy (CIP) and Myopathy (CIM, presentation of Acute Kidney Injury (AKI) grade 3 of need for dialysis, ICU-Length of stay (LOS), Hospital-LOS Additionally, specific interest will go to data regarding potential risk factors for long-term neurocognitive sequels such as: age, social context, pre-existing psychiatric and/or cognitive symptoms, neurological events during ICU hospitalisation (e.g. delirium, ICU-AW, CIP and CIM, stroke (ischemic or hemorrhagic)), need for mechanical ventilation, need for ECMO, need for multiple sedative agents, AKI with or without need for dialysis, ICU-LOS, hospital-LOS, persisting symptoms after discharge, duration of work-related problems (duration of sick leave), increased dependence after discharge, inability to return to original home situation, loss of other family members during follow-up period.
On the other hand, data about long-term outcome will be collected from questionnaires and a possibly clinical interview (for details with regards to this data: see section 'methods').
Data analysis Data will be merged ad patient level. Descriptive statistics will be used to describe baseline characteristics, inpatient course during index hospitalisation and findings (prevalence of the various long-term outcome) obtained from the questionnaires for patient and relatives. Regression analysis will be used to determine associations between patient characteristics, inpatient course and long-term outcomes.
Software Package for the Social Sciences (SPSS) will be used for data analysis.
Data management and ethical considerations Both data extracted from medical records and from the questionnaires will be anonymised before analysis and will be merged at patient level. Data management will be performed by the team of Lynxcare® and by the research team (study nurses and investigators).
Importantly, LynxCare® will only have access to the encrypted data, only the research team will have the key for decoding. This all will be strictly conform the most recent European Union's General Data Protection Regulation (GDPR). Hence patient's privacy will be guaranteed maximally throughout the whole process.
Patients will be asked for oral informed consent during the first phone call, followed by obtaining a written informed consent for both patient and relative, a form that will be included in the bundle sent by post. This written (signed) informed consent is a strict condition prior to enrollment, data collection and analysis.
Ethical approval was given by the Medical Ethical Committee AZ Groeninge (B3962021000047), all patients will give their informed consent prior to data collection and analysis.
- Conditions
- Post Intensive Care Syndrome, PICS, COVID-19, Critically Ill, Mental Health
- Keywords
- COVID-19, ICU survivor, PICS, PICS-F, neurocognitive sequels, Follow-up
- Medical subject headings
- postintensive care syndrome, COVID-19, Critical Illness, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months after ICU discharge
Secondary outcomes (5)
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).
Measured: 18 months after ICU discharge
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).
Measured: 18 months after ICU discharge
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)
Measured: 18 months after ICU discharge
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.
Measured: 18 months after ICU discharge
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.
Measured: 18 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Mar 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stoffel Lamote, General Hospital Groeninge
- Investigators
- Stoffel Lamote, MD, Principal investigator, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348720
- Sponsor's protocol ID
- AZGS2021059
- Acronym
- PICOVIDS
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
PubMed 32250385Gulati A, Pomeranz C, Qamar Z, Thomas S, Frisch D, George G, Summer R, DeSimone J, Sundaram B. A Comprehensive Review of Manifestations of Novel Coronaviruses in the Context of Deadly COVID-19 Global Pandemic. Am J Med Sci. 2020 Jul;360(1):5-34. doi: 10.1016/j.amjms.2020.05.006. Epub 2020 May 11.
PubMed 32620220Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
PubMed 33753937Writing Committee for the COMEBAC Study Group; Morin L, Savale L, Pham T, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Hardy-Leger I, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021 Apr 20;325(15):1525-1534. doi: 10.1001/jama.2021.3331.
PubMed 33729425Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.
PubMed 33836148Jaffri A, Jaffri UA. Post-Intensive care syndrome and COVID-19: crisis after a crisis? Heart Lung. 2020 Nov-Dec;49(6):883-884. doi: 10.1016/j.hrtlng.2020.06.006. Epub 2020 Jun 18. No abstract available.
PubMed 32690219Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.
PubMed 27025938Cameron JI, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, dos Santos C, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Herridge MS; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. One-Year Outcomes in Caregivers of Critically Ill Patients. N Engl J Med. 2016 May 12;374(19):1831-41. doi: 10.1056/NEJMoa1511160.
PubMed 27168433van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016 Jan 21;20:16. doi: 10.1186/s13054-016-1185-9.
PubMed 26792081Azoulay E, Resche-Rigon M, Megarbane B, Reuter D, Labbe V, Cariou A, Geri G, Van der Meersch G, Kouatchet A, Guisset O, Bruneel F, Reignier J, Souppart V, Barbier F, Argaud L, Quenot JP, Papazian L, Guidet B, Thiery G, Klouche K, Lesieur O, Demoule A, Guitton C, Capellier G, Mourvillier B, Biard L, Pochard F, Kentish-Barnes N. Association of COVID-19 Acute Respiratory Distress Syndrome With Symptoms of Posttraumatic Stress Disorder in Family Members After ICU Discharge. JAMA. 2022 Mar 15;327(11):1042-1050. doi: 10.1001/jama.2022.2017.
PubMed 35179564Heesakkers H, van der Hoeven JG, Corsten S, Janssen I, Ewalds E, Simons KS, Westerhof B, Rettig TCD, Jacobs C, van Santen S, Slooter AJC, van der Woude MCE, van den Boogaard M, Zegers M. Clinical Outcomes Among Patients With 1-Year Survival Following Intensive Care Unit Treatment for COVID-19. JAMA. 2022 Feb 8;327(6):559-565. doi: 10.1001/jama.2022.0040.
PubMed 35072716
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05348720
- Acronym / sponsor ID
- PICOVIDS / AZGS2021059
- Conditions
- Post Intensive Care Syndrome, PICS, COVID-19, Critically Ill, Mental Health
- Keywords
- COVID-19, ICU survivor, PICS, PICS-F, neurocognitive sequels, Follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 Apr 2022 (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.
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:
- 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?
- What are important risk factors for these symptoms and disorders?
- What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
Detailed description
Design:
The Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study in a non-university hospital with 31 ICU beds.
Objective:
The study 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:
- 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?
- What are important risk factors for these symptoms and these disorders?
- What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
Patients' recruitment (See section 'inclusion and exclusion criteria' for further details):
Patients admitted to the ICU between 1 March 2020 and 31 May 2021, with respiratory failure primarily due to COVID-19, who survived ICU stay and hospitalisation are eligible and will be contacted by telephone 16 to 18 months after ICU discharge by the research team. Patients will receive information regarding the aim, content and relevance of the study and asked for participation to this study. They will be asked as well whether his or her caregiver the most involved during the ICU stay would participate to the study.
Methods:
Once oral informed consent by telephone will be given, a bundle will be sent to patient and involved relative by post. This bundle contains informed consent, information brochure and several questionnaires.
Questionnaires for patients are:
- Hospital and Depression Scale (HADS anxiety and depression)
- Patient Checklist for DSM-5 (PCL-5) for COVID
- Cognitive Failure Questionnaire (CFQ)
- Short Form 36 Health Survey Questionnaire (SF-36)
- Questionnaire for persistent physical complaints
- Rockwood Clinical Frailty Scale
- Patient Continuity of Care Questionnaire adjusted (PCCQ): subscales relationship in hospital, information transfer)
- Socio-demographic questionnaire
Caregivers will receive the same questionnaires except for the SF-36, the questionnaire assessing persistent physical complaints and the Rockwood Clinical Frailty Scale as these one are not applicable to them, while a Caregiver Reaction Assessment (CRA) scale questionnaire will be added for this cohort.
Consequently psychological, cognitive and physical symptoms, clinical frailty, satisfaction level about care and socio-demographic factors will be assessed.
There are Dutch, French and English versions of this bundle available, as preferred by patient and relative.
Patient and caregiver will be contacted a second time by telephone 10 to 14 days after the first call for verifying whether there are remaining questions after receiving the bundle. A second bundle will be sent by post in case of the first one would have been lost or patient and/or caregiver couldn't be reached.
Questionnaires will be analysed by two members of the research team. Patients and caregivers scoring more than 7 on the HADS-Anxiety, more than 8 on the HADS-Depression or more than 32 on the PCL-5 COVID questionnaire will be considered as having symptoms of respectively anxiety, depression and PTSD. Subsequently, they will be invited for a clinical and structured interview, using the Mini-International Neuropsychiatric Interview (MINI), the Clinician-Administered PTSD scale (CAPS) and the Montreal cognitive Assessment (MoCa). A psychiatrist and clinical psychologist will conduct this interview. Consequently, diagnosis of Generalised Anxiety Disorder (GAD), Depression and PTSD according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as well as cognitive impairment could be established.
Data Collection:
On the one hand, anonymised patient data with respect to the ICU hospitalisation will be collected from patient records (electronic patient records, Patient Data Management System (PDMS), Klinisch Werkstation (KWS), Cyberlab). This data collecting process will be facilitated by LynxCare® company, an Artificial Intelligence (AI) and Natural Language Processing (NLP) based big data platform. This medical data will include: demographics, pre-existing co-morbidities (including Clinical Frailty score (CFS) and Charlson Comorbidity Index, severity of illness scores (APACHE-II score, Simplified Acute Physiology Score (SAPS), Sequential Organ Failure Assessment (SOFA)), specific COVID-treatment, method of respiratory support during ICU stay (High Flow Oxygen, Non-Invasive Ventilation, Mechanical Ventilation, prone ventilation, Extracorporeal Membrane Oxygenation (ECMO), duration of mechanical ventilation, duration of ECMO run, diagnosis of ICU-Acquired Weakness (ICU-AW) or Critical Illness Polyneuropathy (CIP) and Myopathy (CIM, presentation of Acute Kidney Injury (AKI) grade 3 of need for dialysis, ICU-Length of stay (LOS), Hospital-LOS Additionally, specific interest will go to data regarding potential risk factors for long-term neurocognitive sequels such as: age, social context, pre-existing psychiatric and/or cognitive symptoms, neurological events during ICU hospitalisation (e.g. delirium, ICU-AW, CIP and CIM, stroke (ischemic or hemorrhagic)), need for mechanical ventilation, need for ECMO, need for multiple sedative agents, AKI with or without need for dialysis, ICU-LOS, hospital-LOS, persisting symptoms after discharge, duration of work-related problems (duration of sick leave), increased dependence after discharge, inability to return to original home situation, loss of other family members during follow-up period.
On the other hand, data about long-term outcome will be collected from questionnaires and a possibly clinical interview (for details with regards to this data: see section 'methods').
Data analysis Data will be merged ad patient level. Descriptive statistics will be used to describe baseline characteristics, inpatient course during index hospitalisation and findings (prevalence of the various long-term outcome) obtained from the questionnaires for patient and relatives. Regression analysis will be used to determine associations between patient characteristics, inpatient course and long-term outcomes.
Software Package for the Social Sciences (SPSS) will be used for data analysis.
Data management and ethical considerations Both data extracted from medical records and from the questionnaires will be anonymised before analysis and will be merged at patient level. Data management will be performed by the team of Lynxcare® and by the research team (study nurses and investigators).
Importantly, LynxCare® will only have access to the encrypted data, only the research team will have the key for decoding. This all will be strictly conform the most recent European Union's General Data Protection Regulation (GDPR). Hence patient's privacy will be guaranteed maximally throughout the whole process.
Patients will be asked for oral informed consent during the first phone call, followed by obtaining a written informed consent for both patient and relative, a form that will be included in the bundle sent by post. This written (signed) informed consent is a strict condition prior to enrollment, data collection and analysis.
Ethical approval was given by the Medical Ethical Committee AZ Groeninge (B3962021000047), all patients will give their informed consent prior to data collection and analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite outcome: Prevalence of psychiatric symptoms in COVID-19 ICU survivors
Time frame: 18 months after ICU discharge
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.
Composite outcome: Prevalence of psychiatric symptoms among relatives of COVID-19 ICU survivors
Time frame: 18 months after ICU discharge
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.
5 secondary outcomes
Composite outcome: Prevalence of psychiatric disorders among relatives of COVID ICU survivors.
Time frame: 18 months after ICU discharge
Composite outcome: Prevalence of psychiatric disorders among COVID ICU survivors.
Time frame: 18 months after ICU discharge
Prevalence of cognitive impairment in COVID-19 ICU survivors and their relatives
Time frame: 18 months after ICU discharge
Impact of caring for COVID-19 ICU survivor after hospital discharge on the relative
Time frame: 18 months after ICU discharge
Patient and relatives' satisfaction level about continuity of care after hospital discharge
Time frame: 18 months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 32250385Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
- Background: PubMed 32620220Gulati A, Pomeranz C, Qamar Z, Thomas S, Frisch D, George G, Summer R, DeSimone J, Sundaram B. A Comprehensive Review of Manifestations of Novel Coronaviruses in the Context of Deadly COVID-19 Global Pandemic. Am J Med Sci. 2020 Jul;360(1):5-34. doi: 10.1016/j.amjms.2020.05.006. Epub 2020 May 11.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
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- Individual participant dataSharing planned: Undecided
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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.
Stoffel Lamote, MD principal investigator
General Hospital Groeninge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome and PICS, run by General Hospital Groeninge at 1 site in Belgium.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Belgium. 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?
Results are not available in the source record.
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?
Composite outcome: Prevalence of psychiatric symptoms in COVID-19 ICU survivors (time frame: 18 months after ICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348720, which also lists 16 linked publications.
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 27 Apr 2022.