Post Intensive Care Syndrome in COVID19 Patients (PICS-COVID19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04422444|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment|
|COVID19 Post Intensive Care Unit Syndrome||Diagnostic Test: Questionnaires|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
- Diagnostic Test: Questionnaires
Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422444
|Contact: SOL FERNANDEZ, PhD||0034937231010 ext email@example.com|
|Corporació Parc Taulí||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Sol Fernandez-Gonzalo, PhD 937231010 ext 22065 firstname.lastname@example.org|