Skip to main content
Clinical Trials/NCT05813574
NCT05813574
Completed
Not Applicable

Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands

Medisch Spectrum Twente1 site in 1 country835 target enrollmentJuly 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Long COVID-19
Sponsor
Medisch Spectrum Twente
Enrollment
835
Locations
1
Primary Endpoint
General health perception
Status
Completed
Last Updated
last year

Overview

Brief Summary

COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has a devastating effect on human lives, including over 6.6 million death as of November 2022. Furthermore, many individuals continue to experience persisting sequelae after the initial infection. Little is known about the impact of undergoing COVID-19 hospitalisation. Hence, the investigators propose an observational longitudinal study in a cohort of COVID-19 survivors after hospital discharge, to examine their perspectives on their health, health-related quality of life, and persistence of common COVID-19 symptoms, such as fatigue, dyspnoea and anxiety. Potential influencing socio-demographic and biological factors will additionally assessed.

Registry
clinicaltrials.gov
Start Date
July 28, 2020
End Date
November 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harald E. Vonkeman

Principle Investigator

Medisch Spectrum Twente

Eligibility Criteria

Inclusion Criteria

  • Ages ≥18 years
  • PCR-confirmed SARS-CoV-2 infection and hospital admission
  • Proficiency in Dutch
  • Providing informed consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

General health perception

Time Frame: at 12 months after hospital discharge

measured by Short Form 36 Health Survey (SF-36)

Secondary Outcomes

  • Health Status Scale(at 3, 6, 9 and 12 months)
  • Experience sampling study measuring fatigue(Six times a day over 14 days)
  • Incidence, severity and course of Post-Traumatic Stress Disorder(at 3, 6, 9 and 12 months)
  • Experience sampling study measuring severity and daily course of positive and negative affect(Six times a day over 14 days)
  • Positive Health(at 3, 6, 9 and 12 months)
  • Incidence, severity and course of Dyspnoea(at 3, 6, 9 and 12 months)
  • Incidence, severity and course of Sleep(at 3, 6, 9 and 12 months)
  • Experience sampling study measuring health status(Once a day for 14 days)
  • Health Status(at 3, 6, 9 and 12 months)
  • Experience sampling study measuring pain(Six times a day over 14 days)
  • Health-related quality of life(at 3, 6, 9 and 12 months)
  • Incidence, severity and course of Fatique(at 3, 6, 9 and 12 months)
  • Experience sampling study measuring dyspnoea(Six times a day over 14 days)
  • Experience sampling study measuring cognitive functioning(Six times a day over 14 days)
  • Experience sampling study measuring naps(Once a day for 14 days)
  • Experience sampling study measuring daily activity(Six times a day over 14 days)
  • Experience sampling study measuring sleep(Once a day for 14 days)

Study Sites (1)

Loading locations...

Similar Trials