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| Name | Class |
|---|---|
| University of Twente | OTHER |
| Ziekenhuisgroep Twente | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 survivors | COVID-19 survivors: patients (≥18 years old) who were tested positive for SARS-CoV-2 infection as confirmed by polymerase-chain-reaction (PCR) testing and were subsequently hospitalised, were followed after discharge from hospitals in Enschede (MST), Hengelo or Almelo (ZGT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational patient reported outcomes | Other | Of COVID-19 patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| General health perception | measured by Short Form 36 Health Survey (SF-36) | at 12 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Patients (≥18 years old) with SARS-CoV-2 infection confirmed by PCR, and hospitalised and subsequently discharged from MST or ZGT hospital
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| Name | Affiliation | Role |
|---|---|---|
| Harald E. Vonkeman, PhD | Medisch Spectrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Overijssel | 7512KZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36436226 | Result | 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. | |
| 36293582 |
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Upon reasonable request
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Experience sampling study measuring naps | naps (frequency and duration; single-item | Once a day for 14 days |
| 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 |
| 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |