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

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.

Study Overview

• Status: Completed
• Conditions: COVID19; Post Intensive Care Unit Syndrome
• Intervention / Treatment: Diagnostic test: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients with COVID19

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every month during a 12 months follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: SOL FERNANDEZ, PhD, Institut d'Investigació i Innovació Parc Taulí (I3PT)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 2020/577

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No