Post Intensive Care Syndrome in COVID19 Patients

COVID19 Clinical Trial

— PICS-COVID19  

Official title:

Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422444
• Other study ID #: 2020/577
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2023
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2022
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Post Intensive Care Unit Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Corporació Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.