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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard oxygen group | telephone interview comprising a quality of life questionnaire |
| |
| awake prone group | telephone interview comprising a quality of life questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality of life questionnaire | Other | telephone interview to assess mortality and quality of life in the population included in a trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| EURO 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 | 2 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at last follow-up time beyond 2 years after randomization | an average of 2 years follow up | |
| Assessment of autonomy | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital Tours | Tours | 37000 | France |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Assessment of mobility | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
| Assessment of performance of daily activities | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
| Assessment of pain and discomfort | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
| Assessment of anxiety and depression | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
| Number of points on the visual analog scale | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up |
| Hospitalisations | Number of new hospitalizations during follow-up period | an average of 2 years follow up |
| Family situation | Change of family situation | before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up. |
| Employment status | Change of employment status | 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 | an average of 2 years follow up |