Clinical trial NCT05813574: Long Term Impact of COVID-19
Official title: Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long COVID-19
Post-COVID-19 Syndrome
COVID-19
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Ziekenhuisgroep Twente
First posted: 2023-04-14
Enrollment: 835
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (≥18 years old) with SARS-CoV-2 infection confirmed by PCR, and hospitalised and subsequently discharged from MST or ZGT hospital

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: General health perception
timeFrame: at 12 months after hospital discharge
Secondary outcomes:
measure: Health-related quality of life
timeFrame: at 3, 6, 9 and 12 months
measure: Health Status
timeFrame: at 3, 6, 9 and 12 months
measure: Health Status Scale
timeFrame: at 3, 6, 9 and 12 months
measure: Positive Health
timeFrame: at 3, 6, 9 and 12 months
measure: Incidence, severity and course of Fatique
timeFrame: at 3, 6, 9 and 12 months
measure: Incidence, severity and course of Dyspnoea
timeFrame: at 3, 6, 9 and 12 months
measure: Incidence, severity and course of Sleep
timeFrame: at 3, 6, 9 and 12 months
measure: Incidence, severity and course of Post-Traumatic Stress Disorder
timeFrame: at 3, 6, 9 and 12 months
measure: Experience sampling study measuring fatigue
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring dyspnoea
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring cognitive functioning
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring pain
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring severity and daily course of positive and negative affect
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring daily activity
timeFrame: Six times a day over 14 days
measure: Experience sampling study measuring sleep
timeFrame: Once a day for 14 days
measure: Experience sampling study measuring naps
timeFrame: Once a day for 14 days
measure: Experience sampling study measuring health status
timeFrame: Once a day for 14 days
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
affiliation: Medisch Spectrum Twente
name: Harald E. Vonkeman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wensink M, Schaap G, Ten Klooster PM, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. Physical and mental fatigue in post-COVID syndrome and their associations over time: A small-sample ESM-study to explore fatigue, quality of sleep and behaviours. J Psychosom Res. 2023 Jan;164:111084. doi: 10.1016/j.jpsychores.2022.111084. Epub 2022 Nov 17.
citation: Schaap G, Wensink M, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. "It Really Is an Elusive Illness"-Post-COVID-19 Illness Perceptions and Recovery Strategies: A Thematic Analysis. Int J Environ Res Public Health. 2022 Oct 11;19(20):13003. doi: 10.3390/ijerph192013003.