Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Fat free mass by dual-energy X-ray (DEXA)-scan
研究概览
简要总结
This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients not willing to participate;
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
结局指标
主要结局
Fat free mass by dual-energy X-ray (DEXA)-scan
时间窗: 1 year post-infection
Total fat free mass will be measured using a DEXA-scan.
Lean mass by dual-energy X-ray (DEXA)-scan
时间窗: 1 year post-infection
Total lean mass will be determined using a DEXA-scan.
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)
时间窗: 1 year post-infection
Vertebral fracture assessment will be determined using a DEXA-scan.
Adipose tissue cross sectional area on chest CT-scan
时间窗: 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
时间窗: 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
时间窗: 1 year post-infection
A hydraulic grip strength dynamometer will be used to measure the maximal handgrip strength.
Dietary intake by a food diary
时间窗: 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
时间窗: 1 year post-infection
The PSS will retrieve a total score of 0-40 in which lower scores indicate higher stress levels.
Height will be measured using a stadiometer
时间窗: 1 year post-infection
Height will be measured using a stadiometer.
Lung function measured with spirometry
时间窗: 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
时间窗: 1 year post-infection
To determine diffusion capacity for carbon monoxide
(Persistent) lung damage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 year post-infection
Weight will be measured on a weighing scale.
Fasted resting energy expenditure by indirect calorimetry (ventilated hood)
时间窗: 1 year post-infection
VO2 and VCO2 will be measured to determine energy expenditure.
Waist circumference
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 1 year post-infection
Total fat mass and fat percentage as well as visceral fat mass will be measured using a DEXA-scan.
Body mass index (BMI) will be calculated from the weight and height
时间窗: 1 year post-infection
Weight and height will be combined to report BMI in (kg/m\^2)
Resting blood pressure
时间窗: 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
时间窗: 1 year post-infection
Six minute walking distance will be determined.
Maximal heart rate during cardiopulmonary cycling exercise test (CPET)
时间窗: 1 year post-infection
Maximal heart will be measured during the CPET.
Respiratory muscle strength by mouth pressure
时间窗: 1 year post-infection
Inspiratory and expiratory mouth pressure will be measured.
Lower extremity muscle strength by measuring isometric muscle strength
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 1 year post-infection
The mMRC will retrieve a total score of 0-5 in which higher levels indicate more dyspnea.
Fasted lipid profile
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 1 year post-infection
Maximal O2 consumption and CO2 production will be determined during the CPET.
Cognitive function using the cognitive failure questionnaire (CFQ)
时间窗: 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.
次要结局
- Medical history(1 year post-infection)
- Vaccination for COVID-19(1 year post-infection)
- Medication use(1 year post-infection)
- Treatments/therapies after SARS-CoV-2 infection(1 year post-infection)
- Re-infection with COVID-19(1 year post-infection)