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

Completed

• Conditions: Coronavirus Infection; Quality of Life; Long-term Outcomes
• Interventions: Other: COVID-19 Severity

• Registration Number: NCT04376658
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Study Start: 2020-07-15
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1508

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2 (Coalition II)	COVID-19 Severity	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.
Cohort 5 (Coalition VI)	COVID-19 Severity	Adult hospitalized patients with proven SARS-Cov-2, needing oxygen supplementation to maintain SpO2 \> 93%, and two or more of the following inflammatory tests: D-dimer \> 1,000 ng/mL; C reactive protein (CRP) \> 5 mg/dL; Ferritin \> 300 mg/dL; Lactate dehydrogenase (LDH) \> upper limit of normal
Cohort 1 (Coalition I)	COVID-19 Severity	Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.
Cohort 3 (Coalition III)	COVID-19 Severity	Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition
Cohort 4 (Coalition IV)	COVID-19 Severity	Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range

Primary Outcome Measures

Name	Time	Method
One-year utility score of health-related quality of life	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

Name	Time	Method
Score of self-rated health	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).
Score of Instrumental Activities of Daily Living	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).
Score of dyspnea	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.
Symptoms of posttraumatic stress disorder	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).
Utility score of health-related quality of life at 3, 6, and 9 months	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).
Incidence of rehospitalizations	The outcome will be assessed 3, 6, 9 and 12 months after enrollment.	Incidence of all-cause rehospitalizations.
Percentage of return to work or study	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.
Symptoms of anxiety and depression	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).
Incidence of all-cause mortality	The outcome will be assessed 3, 6, 9 and 12 months after enrollment.	Incidence of all-cause mortality.
Percentage of long-term ventilatory support need	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.

Trial Locations

Locations (1)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil