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

• Sponsor: University Hospital, Tours (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06080737
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV 2 Pneumonia	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Mortality at last follow-up time beyond 2 years after randomization [an average of 2 years follow up]

2. Assessment of autonomy [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

3. Assessment of mobility [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

4. Assessment of performance of daily activities [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

5. Assessment of pain and discomfort [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

6. Assessment of anxiety and depression [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

7. Number of points on the visual analog scale [an average of 2 years follow up]

   Subpart of EURO QoL 5D 5L score

8. Hospitalisations [an average of 2 years follow up]

   Number of new hospitalizations during follow-up period

9. Family situation [before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.]

   Change of family situation

10. Employment status [before hospitalization, then at 12, 24 months and at final follow-up.]

    Change of employment status

11. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	university hospital Tours	Tours		France	37000

Sponsors and Collaborators

• University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT06080737
• Other Study ID Numbers: DR 230170 - Long-term APP
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Tours: long-term quality of life; awake prone positioning; acute respiratory distress syndrome
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Oct 12, 2023