Long Term Impact of COVID-19
- Conditions
- Long COVID-19COVID-19Post-COVID-19 Syndrome
- Interventions
- Other: Observational patient reported outcomes
- Registration Number
- NCT05813574
- Lead Sponsor
- Medisch Spectrum Twente
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 835
- Ages ≥18 years
- PCR-confirmed SARS-CoV-2 infection and hospital admission
- Proficiency in Dutch
- Providing informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 survivors Observational patient reported outcomes 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).
- Primary Outcome Measures
Name Time Method General health perception at 12 months after hospital discharge measured by Short Form 36 Health Survey (SF-36)
- Secondary Outcome Measures
Name Time Method 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.
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
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
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
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 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 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)
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.
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
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
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\]
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 naps Once a day for 14 days naps (frequency and duration; single-item
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 sleep Once a day for 14 days Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night?
Trial Locations
- Locations (1)
Medisch Spectrum Twente
🇳🇱Enschede, Overijssel, Netherlands