COVID-19, Long COVID-19, Post-COVID-19 Syndrome
Conditions
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.
Interventions
OTHERObservational patient reported outcomes
Of COVID-19 patients
Sponsors
University of Twente
Ziekenhuisgroep Twente
Medisch Spectrum Twente
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages ≥18 years * PCR-confirmed SARS-CoV-2 infection and hospital admission * Proficiency in Dutch * Providing informed consent
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General health perception | at 12 months after hospital discharge | measured by Short Form 36 Health Survey (SF-36) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experience sampling study measuring naps | Once a day for 14 days | naps (frequency and duration; single-item |
| Health-related quality of life | at 3, 6, 9 and 12 months | 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 |
| Health Status | at 3, 6, 9 and 12 months | 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. |
| Health Status Scale | at 3, 6, 9 and 12 months | Measured by EQ Visual Analogue Scale for self-rated health. Min = 0, Max = 100, where higher scores indicate better health outcomes. |
| Positive Health | at 3, 6, 9 and 12 months | measured by my Positive Health\]): Min = 0, Max = 10, where higher scores indicate better health outcomes |
| Incidence, severity and course of Fatique | at 3, 6, 9 and 12 months | measured by Short Fatique Questionnaire; min = 4, max = 28, higher scores indicating worse fatigue\] |
| Incidence, severity and course of Dyspnoea | at 3, 6, 9 and 12 months | measured by modified Mental Research Council (mMRC) scale; min = 1, max = 6, higher scores indicating worse dyspnoea |
| Incidence, severity and course of Sleep | at 3, 6, 9 and 12 months | measured by unvalidated single-item question min = 1, max = 5, higher scores indicating worse sleep |
| Experience sampling study measuring sleep | Once a day for 14 days | Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night? |
| Experience sampling study measuring fatigue | Six times a day over 14 days | Fatigue (physical, and mental), 1-7, as single-item with higher scores indicating worse health outcomes |
| Experience sampling study measuring dyspnoea | Six times a day over 14 days | Dyspnoea (1 - 7), as single-item with higher scores indicating worse health outcomes |
| Experience sampling study measuring cognitive functioning | Six times a day over 14 days | cognitive functioning, 0 - 10, as single-item with higher scores indicating worse health outcomes |
| Experience sampling study measuring pain | Six times a day over 14 days | 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 |
| Experience sampling study measuring severity and daily course of positive and negative affect | Six times a day over 14 days | 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 |
| Experience sampling study measuring daily activity | Six times a day over 14 days | 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… |
| Experience sampling study measuring health status | Once a day for 14 days | Self-reported health status (EQ-VAS of the EQ-5D-5L; 0 - 100; higher scores indicating better health outcomes) |
| Incidence, severity and course of Post-Traumatic Stress Disorder | at 3, 6, 9 and 12 months | measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version |
Countries
Netherlands
Outcome results
None listed