Long Term Impact of COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05813574
• Other study ID #: Long COVID
• Status: Active, not recruiting
• Start date: July 28, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Medisch Spectrum Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 835
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• Long COVID-19
• Post-COVID-19 Syndrome

Intervention

Other:
• Observational patient reported outcomes
Of COVID-19 patients

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	University of Twente, Ziekenhuisgroep Twente

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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: 10.339 — View 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 Ps — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General health perception	measured by Short Form 36 Health Survey (SF-36)	at 12 months after hospital discharge
Secondary	Health-related quality of life	measured by Short Form 36 Health Survey (SF-36). Physical role limitations, bodily pain, general health perceptions vitality, social functioning, emotional role limitations and mental health. Min=0, Max=100 where higher scores indicate better health outcomes	at 3, 6, 9 and 12 months
Secondary	Health Status	measured by EuroQol 5d(EQ-5D). Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Min = 1, Max = 5, where higher scores indicate worse health outcomes.	at 3, 6, 9 and 12 months
Secondary	Health Status Scale	Measured by EQ Visual Analogue Scale for self-rated health. Min = 0, Max = 100, where higher scores indicate better health outcomes.	at 3, 6, 9 and 12 months
Secondary	Positive Health	measured by my Positive Health]): Min = 0, Max = 10, where higher scores indicate better health outcomes	at 3, 6, 9 and 12 months
Secondary	Incidence, severity and course of Fatique	measured by Short Fatique Questionnaire; min = 4, max = 28, higher scores indicating worse fatigue]	at 3, 6, 9 and 12 months
Secondary	Incidence, severity and course of Dyspnoea	measured by modified Mental Research Council (mMRC) scale; min = 1, max = 6, higher scores indicating worse dyspnoea	at 3, 6, 9 and 12 months
Secondary	Incidence, severity and course of Sleep	measured by unvalidated single-item question min = 1, max = 5, higher scores indicating worse sleep	at 3, 6, 9 and 12 months
Secondary	Incidence, severity and course of Post-Traumatic Stress Disorder	measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version	at 3, 6, 9 and 12 months
Secondary	Experience sampling study measuring fatigue	Fatigue (physical, and mental), 1-7, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Secondary	Experience sampling study measuring dyspnoea	Dyspnoea (1 - 7), as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Secondary	Experience sampling study measuring cognitive functioning	cognitive functioning, 0 - 10, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Secondary	Experience sampling study measuring pain	pain (headache, joint pain, chest pain or discomfort, and pain elsewhere/non-specific; 0 - 10, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Secondary	Experience sampling study measuring severity and daily course of positive and negative affect	Positive (excited, relaxed, satisfied, thankful, and happy) and negative (anxious, gloomy, sad, irritable, and disappointed) affect (all single-items; 1 - 7, higher scores indicating better and worse outcomes for positive and negative affect respectively	Six times a day over 14 days
Secondary	Experience sampling study measuring daily activity	Type of activity just before measurement; o Options: 1: nothing; 2: strenuous relaxation (for example walking, riding a bike, gardening); 3: passive relaxation (for example watching television, reading a book); 4: sleeping or resting; 5: Work/study; 6: household chores; 7: Eating/drinking; 8: self-care (for example bodily hygiene, medication); 9: On the go; 10: social interaction; 11: Something else, namely…	Six times a day over 14 days
Secondary	Experience sampling study measuring sleep	Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night?	Once a day for 14 days
Secondary	Experience sampling study measuring naps	naps (frequency and duration; single-item	Once a day for 14 days
Secondary	Experience sampling study measuring health status	Self-reported health status (EQ-VAS of the EQ-5D-5L; 0 - 100; higher scores indicating better health outcomes)	Once a day for 14 days