NCT04422444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

June 4, 2020

Last Update Submit

March 21, 2023

Conditions

COVID19Post Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months

    Every month during a 12 months follow-up period

  • Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months

    Every month during a 12 months follow-up period

  • Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months

    Every month during a 12 months follow-up period

  • 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.

Interventions

QuestionnairesDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients with COVID19

You may qualify if:

  • Patients admitted to ICU for COVID 19

You may not qualify if:

  • Mental health diagnosis previous to the COVID19 infection
  • Acquired brain damage or neurological disease previous to the COVID19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (3)

  • Fernandez-Gonzalo S, Navarra-Ventura G, Goma G, Godoy-Gonzalez M, Oliveras L, Ridao Sais N, Espinal C, Fortia C, De Haro C, Ochagavia A, Jodar M, Forne C, Santos-Pulpon V, Sarlabous L, Bacardit N, Subira C, Fernandez R, Palao D, Roca O, Blanch L, Lopez-Aguilar J. Characterization of postintensive care syndrome in a prospective cohort of survivors of COVID-19 critical illness: a 12-month follow-up study. Can J Anaesth. 2024 Sep;71(9):1282-1301. doi: 10.1007/s12630-024-02811-4. Epub 2024 Sep 9.

    PMID: 39251486DERIVED

  • Navarra-Ventura G, Godoy-Gonzalez M, Goma G, Jodar M, Sarlabous L, Santos-Pulpon V, Xifra-Porxas A, de Haro C, Roca O, Blanch L, Lopez-Aguilar J, Fernandez-Gonzalo S. Occurrence, co-occurrence and persistence of symptoms of depression and post-traumatic stress disorder in survivors of COVID-19 critical illness. Eur J Psychotraumatol. 2024;15(1):2363654. doi: 10.1080/20008066.2024.2363654. Epub 2024 Jun 17.

    PMID: 38881386DERIVED

  • Godoy-Gonzalez M, Navarra-Ventura G, Goma G, de Haro C, Espinal C, Fortia C, Ridao N, Miguel Rebanal N, Oliveras-Furriols L, Subira C, Jodar M, Santos-Pulpon V, Sarlabous L, Fernandez R, Ochagavia A, Blanch L, Roca O, Lopez-Aguilar J, Fernandez-Gonzalo S. Objective and subjective cognition in survivors of COVID-19 one year after ICU discharge: the role of demographic, clinical, and emotional factors. Crit Care. 2023 May 15;27(1):188. doi: 10.1186/s13054-023-04478-7.

    PMID: 37189173DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • SOL FERNANDEZ, PhD

    Institut d'Investigació i Innovació Parc Taulí (I3PT)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral neuropsychology researcher

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 1, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

ES(1)