PICS-COVID19: Post Intensive Care Syndrome in COVID19 Patients

• Sponsor: Corporacion Parc Tauli (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04422444
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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	Phase
COVID19; Post Intensive Care Unit Syndrome	Diagnostic Test: Questionnaires

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Jun 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corporació Parc Taulí	Sabadell	Barcelona	Spain	08208

Sponsors and Collaborators

• Corporacion Parc Tauli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol Fernandez-Gonzalo, Postdoctoral neuropsychology researcher, Corporacion Parc Tauli
• ClinicalTrials.gov Identifier: NCT04422444
• Other Study ID Numbers: 2020/577
• First Posted: Jun 9, 2020
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Syndrome

Study Results

No Results Posted as of Aug 4, 2021