Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
- Conditions
- Covid19
- Registration Number
- NCT04794985
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.
- Detailed Description
Rationale: Within the Netherlands, more than 1 million people have been infected with SARS-CoV-2, also known as COVID-19. Although the mortality rate is considerable, the vast majority of COVID-19 patients survive the infection. Preliminary findings show that a majority of COVID-19 survivors still experience health problems 3 months after the infection, including reduced lung diffusion capacity, low exercise capacity, muscle weakness, mental problems and reduced cognitive function resulting in a generally poor health status. Whether these health consequences persist on the long-term is unknown.
Objective: To assess the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.
Study design: A multicenter prospective observational study performed within the MUMC+ and VieCuri Medical Center.
Study population: 200 COVID-19 survivors of the MUMC+, VieCuri Medical Center or Zuyderland Medical Center, both hospitalized (ICU and non-ICU admitted) as well as non-hospitalized patients.
Main study parameters/endpoints: Outcome parameters include objectively and subjectively measured multidimensional health outcomes including physiological and metabolic health, physical capability, cognitive function, psychosocial well-being, social well-being, patient reported outcomes as well as potential determinants of these multidimensional health outcomes (e.g. treatment during/after SARS-CoV-2 infection, vaccination, comorbidities, medication use etc.). Outcomes will be measured during a one-day study visit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will benefit from participating within this study, because their general health will be evaluated in detail and from a multidimensional perspective. Furthermore, subjects will be informed on their multidimensional health outcomes and will receive a lifestyle advice tailored to their health status. Risks and inconveniences are limited to the time investment associated with the completion of the questionnaires and the study visit. During the study visit various non-invasive measurements as well as minor invasive blood sampling will be performed.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 140
-
COVID-19 positive based on:
- Confirmed RT-PCR;
- Proven serology for SARS-COV-2 with clearly associated complaints for a SARS-COV-2 infection;
- CO-RADS score of 4 or more with a proven serology for SARS-CoV-2 afterwards.
-
Age of ≥18 years;
-
Able to provide informed consent;
-
Understanding of Dutch language.
- Patients not willing to participate;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat free mass by dual-energy X-ray (DEXA)-scan 1 year post-infection Total fat free mass will be measured using a DEXA-scan.
Lean mass by dual-energy X-ray (DEXA)-scan 1 year post-infection Total lean mass will be determined using a DEXA-scan.
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan) 1 year post-infection Vertebral fracture assessment will be determined using a DEXA-scan.
Adipose tissue cross sectional area on chest CT-scan 1 year post-infection Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
Fasting glucose levels 1 year post-infection Fasting glucose levels will be determined in sampled blood as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Upper extremity muscle strength by measuring handgrip strength 1 year post-infection A hydraulic grip strength dynamometer will be used to measure the maximal handgrip strength.
Dietary intake by a food diary 1 year post-infection A 3-day food diary will be used to investigate the dietary intake.
The Perceived stress scale (PSS) to determine stress levels 1 year post-infection The PSS will retrieve a total score of 0-40 in which lower scores indicate higher stress levels.
Lung function measured with spirometry 1 year post-infection Pre- and post-bronchodilator spirometry will be performed to determine forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).
Diffusion capacity measured with the single breath method 1 year post-infection To determine diffusion capacity for carbon monoxide
(Persistent) lung damage 1 year post-infection To determine lung damage a chest CT-scan will be obtained. To evaluate whether lung damage is persistent, scans will be compared to scans obtained during COVID-19 screening or COVID-19 after care.
Bone mineral density by dual-energy X-ray (DEXA)-scan 1 year post-infection Total bone mineral density (BMD) as well as BMD of the lumbar spine and total hip-neck will be determined using a DEXA-scan.
Muscle cross sectional area on chest CT-scan 1 year post-infection Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
Weight will be measured on a weighing scale 1 year post-infection Weight will be measured on a weighing scale.
Fasted resting energy expenditure by indirect calorimetry (ventilated hood) 1 year post-infection VO2 and VCO2 will be measured to determine energy expenditure.
Waist circumference 1 year post-infection Waist circumference will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Cognitive function by Montreal Cognitive Assessment (MOCA) 1 year post-infection The MOCA will lead to a total score of 0-30, in which lower scores indicate less cognitive function.
Smell by the Sniffing Sticks treshold test 1 year post-infection The average of the last four reversal points is used as final threshold score.
Taste and smell function using the taste and smell function questionnaire 1 year post-infection The questionnaire will retrieve a maximal score of 0-52 and 0-44 for taste and smell, respectively, in which higher scores indicate problems with taste and smell function.
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI) 1 year post-infection The total PSQI score will vary between 0-21 in which higher scores indicate poor sleep quality.
Fat mass by dual-energy X-ray (DEXA)-scan 1 year post-infection Total fat mass and fat percentage as well as visceral fat mass will be measured using a DEXA-scan.
Height will be measured using a stadiometer 1 year post-infection Height will be measured using a stadiometer.
Body mass index (BMI) will be calculated from the weight and height 1 year post-infection Weight and height will be combined to report BMI in (kg/m\^2)
Resting blood pressure 1 year post-infection Resting diastolic and systolic blood pressure will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Six minute walking test to determine exercise capacity 1 year post-infection Six minute walking distance will be determined.
Maximal heart rate during cardiopulmonary cycling exercise test (CPET) 1 year post-infection Maximal heart will be measured during the CPET.
Respiratory muscle strength by mouth pressure 1 year post-infection Inspiratory and expiratory mouth pressure will be measured.
Lower extremity muscle strength by measuring isometric muscle strength 1 year post-infection Maximal isometric upper leg muscle strength will be measured of the quadriceps muscle using a Biodex dynamometer.
Mobility using the short physical performance battery (SPPB) 1 year post-infection The SPPB consists of three types of physical maneuvers: the balance test, the gait speed test and the chair stand test leading to a score of 0-12. Lower scores indicate less mobility.
Physical activity level by accelerometry 1 year post-infection An accelerometer will be worn for 7 days to determine physical activity level.
The hospital anxiety and depression scale (HADS) to determine anxiety and depression levels 1 year post-infection The HADS will retrieve a total score of 0-21 in which lower levels indicate higher levels of anxiety or depression.
Subjective multidimensional health status by euroqol-5 dimensions 1 year post-infection The EQ-5D consists of 5 domains (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) and a visual analogue scale.
Dyspnea using the modified medical research council (mMRC) 1 year post-infection The mMRC will retrieve a total score of 0-5 in which higher levels indicate more dyspnea.
Fasted lipid profile 1 year post-infection Fasted high-density, low-density and total lipoprotein levels (HDL and LDL) as well as triglycerides will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Taste using the taste strips 'filter paper disc method' test 1 year post-infection A maximum score of 16 correct taste detections can be retrieved indication good taste function.
Perceived social support using the multidimensional scale of perceived social support (MSPSS) 1 year post-infection A total score of 12-84 can be retrieved in which lower scores indicate lower levels of social support.
Loneliness using the loneliness scale (LS) 1 year post-infection The LS will retrieve a total score of 0-11 in which higher scores indicate strong loneliness.
Fatigue using the Checklist Individual Strength (CIS) 1 year post-infection The CIS will retrieve a total score of 20-140 in which higher scores indicate more fatigue.
General pain using the Visual Analogue Scale (VAS) 1 year post-infection A total score of 0-100 will be retrieved in which higher scores indicate more pain.
Peak work rate by cardiopulmonary cycling exercise test (CPET) 1 year post-infection Maximal work rate (W) will be determined during the CPET
Peak O2-consumption and CO2-production by cardiopulmonary cycling exercise test (CPET) 1 year post-infection Maximal O2 consumption and CO2 production will be determined during the CPET.
Cognitive function using the cognitive failure questionnaire (CFQ) 1 year post-infection The CFQ will lead to a total score of 0-100. A higher total score indicates more subjective cognitive failure. Additionally, four subscales can be identified, related to distraction, distraction in social situations, names and words and orientation.
- Secondary Outcome Measures
Name Time Method Medical history 1 year post-infection Retrieved from medical records and self-report
Vaccination for COVID-19 1 year post-infection Retrieved from medical records and self-report
Medication use 1 year post-infection Retrieved from medical records and self-report
Treatments/therapies after SARS-CoV-2 infection 1 year post-infection Retrieved from medical records and self-report
Re-infection with COVID-19 1 year post-infection Retrieved from medical records and self-report
Trial Locations
- Locations (3)
Zuyderland Medical Center
🇳🇱Heerlen, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
VieCuri Medical Center
🇳🇱Venlo, Netherlands