Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)
All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.
Study Type
OBSERVATIONAL
Enrollment
300
telephone interview to assess mortality and quality of life in the population included in a trial
university hospital Tours
Tours, France
RECRUITINGEURO QoL 5D 5L quality-of-life score
Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score
Time frame: 2 years after randomization
Mortality at last follow-up time beyond 2 years after randomization
Time frame: an average of 2 years follow up
Assessment of autonomy
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Assessment of mobility
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Assessment of performance of daily activities
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Assessment of pain and discomfort
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Assessment of anxiety and depression
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Number of points on the visual analog scale
Subpart of EURO QoL 5D 5L score
Time frame: an average of 2 years follow up
Hospitalisations
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Number of new hospitalizations during follow-up period
Time frame: an average of 2 years follow up
Family situation
Change of family situation
Time frame: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.
Employment status
Change of employment status
Time frame: before hospitalization, then at 12, 24 months and at final follow-up.
Subgroup analysis:
analysis of primary endpoint, mortality, and subparts of the EURO QoL 5D 5L score in subgroups of patients who were intubated or not during follow-up in the initial meta-assay
Time frame: an average of 2 years follow up