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Remote Video Consultation for Quality of Life Assessment in Patients Hospitalised After COVID-19 Infection (TELECOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714138
Recruitment Status : Completed
First Posted : January 19, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier du Havre

Study Description
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Brief Summary:

Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities.

This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.


Condition or disease
Covid19

Study Design
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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Evaluation of Quality of Life and Functional Capacities in Patients Hospitalised for COVID-19: a Prospective Observational Study
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : March 20, 2021
Actual Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 10 to 12 months after hospital discharge during remote video consultation ]
    Measured with the Short-Form health survey (SF-36) scale (score ranging form 0 (worst score) to 100 (best score) per item)


Secondary Outcome Measures :
  1. Functional capacity [ Time Frame: 10 to 12 months after hospital discharge during remote video consultation ]
    One-minute Sit-to-stand test

  2. Independency [ Time Frame: 10 to 12 months after hospital discharge during remote video consultation ]
    KATZ score (ranging 0 (fully dependent) to 6 (fully independent))


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 adults patients hospitalised at Le Havre hospital between March 1st and May 11th
Criteria

Inclusion Criteria:

  • Adult patient
  • COVID-19 hospitalisation at Le Havre hospital between March 1st and May 11th
  • Non-opposition during first phone contact

Exclusion Criteria:

  • Guardianship
  • Juvenile patients
  • Pregnancy
  • Inability to communicate
  • Cognitive disorders
  • Deceased patient
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714138


Locations
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France
Groupe Hospitalier Du Havre
Montivilliers, Normandie, France, 76290
Sponsors and Collaborators
Groupe Hospitalier du Havre
More Information
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Responsible Party: Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT04714138    
Other Study ID Numbers: 2020-A03110-39
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases