Post Intensive Care Syndrome in COVID19 Patients

Overview

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.

Full Title of Study: “Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2021

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Investigator Details

  • Lead Sponsor
    • Corporacion Parc Tauli
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sol Fernandez-Gonzalo, Postdoctoral neuropsychology researcher – Corporacion Parc Tauli
  • Overall Official(s)
    • SOL FERNANDEZ, PhD, Principal Investigator, Institut d’Investigació i Innovació Parc Taulí (I3PT)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.