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Completed

NCT Number: NCT04376658

Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.

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Key information

Conditions

Quality of Life Coronaviridae Infections Coronavirus Infection Coronavirus Infections Infections Long-term Outcomes Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 years and older
  • Hospitalization due to proven or suspected SARS-CoV-2 infection
  • Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials

Exclusion criteria

  • Death during the hospitalization
  • Absence of telephone contact
  • Absence of proxy for patients with communication difficulties
  • Refusal or withdrawal of agreement to participate

Treatment and study plan

COVID-19 Severity

Other

Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death

Primary outcomes

  1. One-year utility score of health-related quality of life

    Time frame: The outcome will be assessed 12 months after enrollment.

    The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Secondary outcomes

  1. Incidence of all-cause mortality

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    Incidence of all-cause mortality.

  2. Incidence of rehospitalizations

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    Incidence of all-cause rehospitalizations.

  3. Percentage of return to work or study

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.

  4. Score of Instrumental Activities of Daily Living

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).

  5. Score of dyspnea

    Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

    The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms.

  6. Percentage of long-term ventilatory support need

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.

  7. Symptoms of anxiety and depression

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).

  8. Symptoms of posttraumatic stress disorder

    Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

    The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).

  9. Utility score of health-related quality of life at 3, 6, and 9 months

    Time frame: The outcome will be assessed 3, 6, and 9 months after enrollment.

    The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

  10. Score of self-rated health

    Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

    The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Beneficência Portuguesa de São Paulo
  • Brazilian Clinical Research Institute
  • Brazilian Research In Intensive Care Network
  • Hospital Alemão Oswaldo Cruz
  • Hospital Israelita Albert Einstein
  • Hospital Sirio-Libanes
  • Hospital do Coracao

Registry information

Official study title

Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 6, 2020
Registry last updated
Jul 6, 2022

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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