SARS-CoV 2 Pneumonia
Conditions
Keywords
long-term quality of life, awake prone positioning, acute respiratory distress syndrome
Brief summary
Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)
Detailed description
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.
Interventions
OTHERquality of life questionnaire
telephone interview to assess mortality and quality of life in the population included in a trial
Sponsors
University Hospital, Tours
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021). * Patients alive at D28 * No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.
Exclusion criteria
* Patients lost to follow-up after 28 days. * Withdrawal of consent from randomized meta-trial by patient * Vulnerable person: safeguard of justice, curatorship, or guardianship * Patients refusing to answer telephone questionnaire.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EURO QoL 5D 5L quality-of-life score | 2 years after randomization | Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at last follow-up time beyond 2 years after randomization | an average of 2 years follow up | — |
| Assessment of autonomy | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Assessment of mobility | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Assessment of performance of daily activities | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Assessment of pain and discomfort | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Assessment of anxiety and depression | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Number of points on the visual analog scale | an average of 2 years follow up | Subpart of EURO QoL 5D 5L score |
| Hospitalisations | an average of 2 years follow up | Number of new hospitalizations during follow-up period |
| Family situation | before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up. | Change of family situation |
| Employment status | before hospitalization, then at 12, 24 months and at final follow-up. | Change of employment status |
| Subgroup analysis: | an average of 2 years follow up | 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 |
Countries
France
Outcome results
None listed