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Trial record 1 of 1 for:    NCT04376658
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Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

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ClinicalTrials.gov Identifier: NCT04376658
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborators:
Hospital Israelita Albert Einstein
Hospital Sirio-Libanes
Hospital do Coracao
Hospital Alemão Oswaldo Cruz
Beneficência Portuguesa de São Paulo
Brazilian Clinical Research Institute
Brazilian Research In Intensive Care Network
Information provided by (Responsible Party):
Hospital Moinhos de Vento

Brief Summary:
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. Four sets of variables (1-demographic characteristics, 2-pre-morbid state of health, 3-characteristics of acute illness, 4- specific Covid-19 treatments received, and 5-time-updated post-discharge variables (HRQL, physical functional status and symptoms of anxiety, depression, and PTSD) will be assessed as potential risk factors for health-related quality of life and secondary outcomes.

Condition or disease Intervention/treatment
Quality of Life Long-term Outcomes Coronavirus Infection Other: COVID-19

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : July 15, 2022

Group/Cohort Intervention/treatment
Cohort 1
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.
Other: COVID-19
Proven or suspected SARS-Cov-2 infection

Cohort 2
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection needing oxygen supplementation > 4L/min on nasal catheter or HFNC or NIV or MV or ECMO.
Other: COVID-19
Proven or suspected SARS-Cov-2 infection

Cohort 3
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition
Other: COVID-19
Proven or suspected SARS-Cov-2 infection




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376658


Contacts
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Contact: Regis G Rosa, MD 5551994538804 regisgoulartrosa@gmail.com
Contact: Maicon Falavigna, MD maicon.falavigna@hmv.org.br

Locations
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Brazil
Hospital Moinhos de Vento Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Regis G Rosa, MD    +5551994538804    regisgoulartrosa@gmail.com   
Sponsors and Collaborators
Hospital Moinhos de Vento
Hospital Israelita Albert Einstein
Hospital Sirio-Libanes
Hospital do Coracao
Hospital Alemão Oswaldo Cruz
Beneficência Portuguesa de São Paulo
Brazilian Clinical Research Institute
Brazilian Research In Intensive Care Network
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Responsible Party: Hospital Moinhos de Vento
ClinicalTrials.gov Identifier: NCT04376658    
Other Study ID Numbers: Coalition COVID-19: Long-term
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections