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Post Intensive Care Syndrome in COVID19 Patients (PICS-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422444
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sol Fernandez-Gonzalo, Corporacion Parc Tauli

Brief 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. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.

Condition or disease Intervention/treatment
COVID19 Post Intensive Care Unit Syndrome Diagnostic Test: Questionnaires

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2022

Intervention Details:
  • Diagnostic Test: Questionnaires
    Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Measure of independent living skills. Values are from 0 to 8, with higher scores meaning better outcome.

  2. Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months [ Time Frame: Every month during a 12 months follow-up period ]
    Self-report measure of cognitive dysfunction. Values are from 0 to 22, with lower scores meaning better outcome.

  3. Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months [ Time Frame: Every month during a 12 months follow-up period ]
    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.

  4. 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. ]
    Self-report measure of Post Traumatic Stress Disorder (PTSD) symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
ICU patients with COVID19
Criteria

Inclusion Criteria:

  • Patients admitted to ICU for COVID 19

Exclusion Criteria:

  • Mental health diagnosis previous to the COVID19 infection
  • Acquired brain damage or neurological disease previous to the COVID19 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422444


Contacts
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Contact: SOL FERNANDEZ, PhD 0034937231010 ext 22065 msfernandez@tauli.cat

Locations
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Spain
Corporació Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Sol Fernandez-Gonzalo, PhD    937231010 ext 22065    msfernandez@tauli.cat   
Sponsors and Collaborators
Corporacion Parc Tauli
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Responsible Party: Sol Fernandez-Gonzalo, Postdoctoral neuropsychology researcher, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04422444    
Other Study ID Numbers: 2020/577
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes