Post Intensive Care Syndrome in COVID19 Patients

Completed

• Conditions: Post Intensive Care Unit Syndrome; COVID19

• Registration Number: NCT04422444
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Short Form 12 Health Survey (SF12) at 12 month	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

Name	Time	Method
Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months	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 Hospital Anxiety and Depression Scale (HADS) at 12 months	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 Perceived Deficits Questionnaire (PDQ) at 12 months	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 Davidson Trauma Scale (DTS) at 12 months	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.

Trial Locations

Locations (1)

Corporació Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain