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OpenTrials
Completed

NCT Number: NCT04422444

Post Intensive Care Syndrome in COVID19 Patients

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Post Intensive Care Unit Syndrome RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Diagnostic Test

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Acronym: PICS-COVID19

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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