COVID19PICS-COVID19NCT04422444
Post Intensive Care Syndrome in COVID19 Patients
An observational study of COVID19 and Post Intensive Care Unit Syndrome, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID19, Post Intensive Care Unit Syndrome
- What is being tested?
- Questionnaires
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Jun 2022
- How long will I take part?
- 12 Months
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: ICU patients with COVID19
Who may be able to join
- Patients admitted to ICU for COVID 19
Who cannot join
- Mental health diagnosis previous to the COVID19 infection
- Acquired brain damage or neurological disease previous to the COVID19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.
This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.
- Conditions
- COVID19, Post Intensive Care Unit Syndrome
- Being tested
- Questionnaires
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Short Form 12 Health Survey (SF12) at 12 month
Health related quality of live scale. Values are directly transformed in T scores (mean=50; SD=10), with higher scores meaning better outcome.
Measured: Every month during a 12 months follow-up period
Secondary outcomes (4)
Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months
Measure of independent living skills. Values are from 0 to 8, with higher scores meaning better outcome.
Measured: Every month during a 12 months follow-up period
Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months
Self-report measure of cognitive dysfunction. Values are from 0 to 22, with lower scores meaning better outcome.
Measured: Every month during a 12 months follow-up period
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months
A self-assessment instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient. Values are from 0 to 42, with lower scores meaning better outcome.
Measured: Every month during a 12 months follow-up period
Change from baseline Davidson Trauma Scale (DTS) at 12 months
Self-report measure of Post Traumatic Stress Disorder (PTSD) symptoms.
Measured: Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies 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
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sol Fernandez-Gonzalo, Corporacion Parc Tauli
- Investigators
- SOL FERNANDEZ, PhD, Principal investigator, Institut d'Investigació i Innovació Parc Taulí (I3PT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422444
- Sponsor's protocol ID
- 2020/577
- Acronym
- PICS-COVID19
- Status last verified
- Mar 2023
- First submitted
- 4 Jun 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez-Gonzalo S, Navarra-Ventura G, Goma G, Godoy-Gonzalez M, Oliveras L, Ridao Sais N, Espinal C, Fortia C, De Haro C, Ochagavia A, Jodar M, Forne C, Santos-Pulpon V, Sarlabous L, Bacardit N, Subira C, Fernandez R, Palao D, Roca O, Blanch L, Lopez-Aguilar J. Characterization of postintensive care syndrome in a prospective cohort of survivors of COVID-19 critical illness: a 12-month follow-up study. Can J Anaesth. 2024 Sep;71(9):1282-1301. doi: 10.1007/s12630-024-02811-4. Epub 2024 Sep 9.
PubMed 39251486Navarra-Ventura G, Godoy-Gonzalez M, Goma G, Jodar M, Sarlabous L, Santos-Pulpon V, Xifra-Porxas A, de Haro C, Roca O, Blanch L, Lopez-Aguilar J, Fernandez-Gonzalo S. Occurrence, co-occurrence and persistence of symptoms of depression and post-traumatic stress disorder in survivors of COVID-19 critical illness. Eur J Psychotraumatol. 2024;15(1):2363654. doi: 10.1080/20008066.2024.2363654. Epub 2024 Jun 17.
PubMed 38881386Godoy-Gonzalez M, Navarra-Ventura G, Goma G, de Haro C, Espinal C, Fortia C, Ridao N, Miguel Rebanal N, Oliveras-Furriols L, Subira C, Jodar M, Santos-Pulpon V, Sarlabous L, Fernandez R, Ochagavia A, Blanch L, Roca O, Lopez-Aguilar J, Fernandez-Gonzalo S. Objective and subjective cognition in survivors of COVID-19 one year after ICU discharge: the role of demographic, clinical, and emotional factors. Crit Care. 2023 May 15;27(1):188. doi: 10.1186/s13054-023-04478-7.
PubMed 37189173
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.
- ClinicalTrials.gov ID
- NCT04422444
- Acronym / sponsor ID
- PICS-COVID19 / 2020/577
- Conditions
- COVID19, Post Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 9 Jun 2020 (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.
This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients with COVID19
Key inclusion criteria (1 listed)
- Patients admitted to ICU for COVID 19
Key exclusion criteria (2 listed)
- Mental health diagnosis previous to the COVID19 infection
- Acquired brain damage or neurological disease previous to the COVID19 infection
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 |
|---|---|---|
| QuestionnairesParticipants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status | Diagnostic test | – |
Primary outcome
Change from baseline Short Form 12 Health Survey (SF12) at 12 month
Time frame: Every month during a 12 months follow-up period
Health related quality of live scale. Values are directly transformed in T scores (mean=50; SD=10), with higher scores meaning better outcome.
4 secondary outcomes
Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months
Time frame: Every month during a 12 months follow-up period
Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months
Time frame: Every month during a 12 months follow-up period
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months
Time frame: Every month during a 12 months follow-up period
Change from baseline Davidson Trauma Scale (DTS) at 12 months
Time frame: Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.
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 22 Mar 2023.
- Derived from this study: PubMed 39251486Fernandez-Gonzalo S, Navarra-Ventura G, Goma G, Godoy-Gonzalez M, Oliveras L, Ridao Sais N, Espinal C, Fortia C, De Haro C, Ochagavia A, Jodar M, Forne C, Santos-Pulpon V, Sarlabous L, Bacardit N, Subira C, Fernandez R, Palao D, Roca O, Blanch L, Lopez-Aguilar J. Characterization of postintensive care syndrome in a prospective cohort of survivors of COVID-19 critical illness: a 12-month follow-up study. Can J Anaesth. 2024 Sep;71(9):1282-1301. doi: 10.1007/s12630-024-02811-4. Epub 2024 Sep 9.
- Derived from this study: PubMed 38881386Navarra-Ventura G, Godoy-Gonzalez M, Goma G, Jodar M, Sarlabous L, Santos-Pulpon V, Xifra-Porxas A, de Haro C, Roca O, Blanch L, Lopez-Aguilar J, Fernandez-Gonzalo S. Occurrence, co-occurrence and persistence of symptoms of depression and post-traumatic stress disorder in survivors of COVID-19 critical illness. Eur J Psychotraumatol. 2024;15(1):2363654. doi: 10.1080/20008066.2024.2363654. Epub 2024 Jun 17.
- Derived from this study: PubMed 37189173Godoy-Gonzalez M, Navarra-Ventura G, Goma G, de Haro C, Espinal C, Fortia C, Ridao N, Miguel Rebanal N, Oliveras-Furriols L, Subira C, Jodar M, Santos-Pulpon V, Sarlabous L, Fernandez R, Ochagavia A, Blanch L, Roca O, Lopez-Aguilar J, Fernandez-Gonzalo S. Objective and subjective cognition in survivors of COVID-19 one year after ICU discharge: the role of demographic, clinical, and emotional factors. Crit Care. 2023 May 15;27(1):188. doi: 10.1186/s13054-023-04478-7.
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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.
SOL FERNANDEZ, PhD principal investigator
Institut d'Investigació i Innovació Parc Taulí (I3PT)
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 COVID19 and Post Intensive Care Unit Syndrome, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 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 22 Mar 2023. 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 Spain. 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?
Change from baseline Short Form 12 Health Survey (SF12) at 12 month (time frame: Every month during a 12 months follow-up period). 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 NCT04422444, which also lists 3 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 22 Mar 2023.