Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04794985

Enrollment

140

Registered

2021-03-12

Start date

2022-02-17

Completion date

2024-08-20

Last updated

2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Multidimensional health, COVID-19, Long-term consequences

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Patients not willing to participate; * Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Lean mass by dual-energy X-ray (DEXA)-scan	1 year post-infection	Total lean mass will be determined using a DEXA-scan.
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.
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.
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)	1 year post-infection	Vertebral fracture assessment 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.
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.
Weight will be measured on a weighing scale	1 year post-infection	Weight will be measured on a weighing scale.
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)
Fasted resting energy expenditure by indirect calorimetry (ventilated hood)	1 year post-infection	VO2 and VCO2 will be measured to determine energy expenditure.
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.
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.
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.
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.
Six minute walking test to determine exercise capacity	1 year post-infection	Six minute walking distance will be determined.
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.
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.
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.
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.
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.
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.
Dietary intake by a food diary	1 year post-infection	A 3-day food diary will be used to investigate the dietary intake.
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.

Secondary

Measure	Time frame	Description
Treatments/therapies after SARS-CoV-2 infection	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
Re-infection with 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
Medical history	1 year post-infection	Retrieved from medical records and self-report

Other

Measure	Time frame	Description
Smoking status	1 year post-infection	Based on self-report
Motivation by the Behavioral Regulation in Exercise Questionnaire (BREQ-2)	1 year post-infection	The BREQ-2 will provide several motivation types based on the self-determination theory.
Motivation by the Regulation of Eating Behaviors Questionnaire (REBS)	1 year post-infection	The REBS will provide several motivation types based on the self-determination theory.
Date of SARS-CoV-2 infection	1 year post-infection	The date of the SARS-CoV-2 infection will be extracted from the medical records in order to determine the time since the COVID-19 infection.
Sociodemographics	1 year post-infection	Including age, gender, race, living situation, household composition, marital status, educational level, smoking status, alcohol consumed, employment status, occupation, volunteer work, and income level.

Countries

Netherlands

Outcome results