Back to resultsHRQOL of Life After ECMO Due to COVID-19.
Primary Purpose
ARDS, COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Phone Interview
Sponsored by
About this trial
This is an interventional health services research trial for ARDS
Eligibility Criteria
Inclusion Criteria:
- patients surviving COVID-19 ARDS and ECMO therapy
Exclusion Criteria:
- no consent
Sites / Locations
- Medical University of ViennaRecruiting
Outcomes
Primary Outcome Measures
HRQOL after COVID-19 ARDS and ECMO therapy
Health-related quality of life will be delineated by means of a quantitative questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT05531032
First Posted
August 30, 2022
Last Updated
March 23, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05531032
Brief Title
HRQOL of Life After ECMO Due to COVID-19.
Official Title
Health-related Quality of Life Following Extracorporeal Membrane Oxygenation Due to Coronavirus Disease 2019.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We intend to prospectively investigate physical and mental state (HRQOL) by means of quantitative telephone interviews after hospital discharge in patients surviving COVID-19 ARDS and ECMO therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phone Interview
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Phone Interview
Intervention Description
Phone interview questionnaire
Primary Outcome Measure Information:
Title
HRQOL after COVID-19 ARDS and ECMO therapy
Description
Health-related quality of life will be delineated by means of a quantitative questionnaire.
Time Frame
1 year
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients surviving COVID-19 ARDS and ECMO therapy
Exclusion Criteria:
no consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Hermann, Dr.
Phone
+436644122223
Email
martina.hermann@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Hermann, Dr.
Email
alexander.hermann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Hermann, Dr.
Organizational Affiliation
MUW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Hermann, Dr.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
HRQOL of Life After ECMO Due to COVID-19.
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