Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients (Long-termAPP)

Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial

Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2 Pneumonia
• Intervention / Treatment: Other: quality of life questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • university hospital Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
standard oxygen group; telephone interview comprising a quality of life questionnaire	Other: quality of life questionnaire; telephone interview to assess mortality and quality of life in the population included in a trial
awake prone group; telephone interview comprising a quality of life questionnaire	Other: quality of life questionnaire; telephone interview to assess mortality and quality of life in the population included in a trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: acute respiratory distress syndrome; long-term quality of life; awake prone positioning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: DR 230170 - Long-term APP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No