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OpenTrials
Completed

NCT Number: NCT05813574

Long Term Impact of COVID-19

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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Key information

Conditions

Long COVID-19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages ≥18 years
  • PCR-confirmed SARS-CoV-2 infection and hospital admission
  • Proficiency in Dutch
  • Providing informed consent

Exclusion criteria

  • None

Treatment and study plan

Observational patient reported outcomes

Other

Of COVID-19 patients

Primary outcomes

  1. General health perception

    Time frame: at 12 months after hospital discharge

    measured by Short Form 36 Health Survey (SF-36)

Secondary outcomes

  1. Health-related quality of life

    Time frame: 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

  2. Health Status

    Time frame: 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.

  3. Health Status Scale

    Time frame: 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.

  4. Positive Health

    Time frame: at 3, 6, 9 and 12 months

    measured by my Positive Health]): Min = 0, Max = 10, where higher scores indicate better health outcomes

  5. Incidence, severity and course of Fatique

    Time frame: at 3, 6, 9 and 12 months

    measured by Short Fatique Questionnaire; min = 4, max = 28, higher scores indicating worse fatigue]

  6. Incidence, severity and course of Dyspnoea

    Time frame: at 3, 6, 9 and 12 months

    measured by modified Mental Research Council (mMRC) scale; min = 1, max = 6, higher scores indicating worse dyspnoea

  7. Incidence, severity and course of Sleep

    Time frame: at 3, 6, 9 and 12 months

    measured by unvalidated single-item question min = 1, max = 5, higher scores indicating worse sleep

  8. Incidence, severity and course of Post-Traumatic Stress Disorder

    Time frame: at 3, 6, 9 and 12 months

    measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version

  9. Experience sampling study measuring fatigue

    Time frame: Six times a day over 14 days

    Fatigue (physical, and mental), 1-7, as single-item with higher scores indicating worse health outcomes

  10. Experience sampling study measuring dyspnoea

    Time frame: Six times a day over 14 days

    Dyspnoea (1 - 7), as single-item with higher scores indicating worse health outcomes

  11. Experience sampling study measuring cognitive functioning

    Time frame: Six times a day over 14 days

    cognitive functioning, 0 - 10, as single-item with higher scores indicating worse health outcomes

  12. Experience sampling study measuring pain

    Time frame: 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

  13. Experience sampling study measuring severity and daily course of positive and negative affect

    Time frame: 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

  14. Experience sampling study measuring daily activity

    Time frame: 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…

  15. Experience sampling study measuring sleep

    Time frame: Once a day for 14 days

    Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night?

  16. Experience sampling study measuring naps

    Time frame: Once a day for 14 days

    naps (frequency and duration; single-item

  17. Experience sampling study measuring health status

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Medisch Spectrum Twente

Other

Collaborators

  • University of Twente
  • Ziekenhuisgroep Twente

Registry information

Official study title

Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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