Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population (COVIDAMBUCMA1)

October 14, 2022 updated by: Direction Centrale du Service de Santé des Armées
In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • 1er Centre Médical des Armées

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of military staff followed at the 1st Centre Médical des Armées (Paris, France) who have suffered from COVID-19 and were managed in ambulatory care (COVID+ group) and who have not been infected by SARS-CoV-2 (COVID- group).

Description

Inclusion Criteria:

  • Military personnel
  • COVID+: diagnosed with COVID-19 and managed in ambulatory care since March 14th, 2020
  • COVID-: not having been infected with SARS-CoV-2

Exclusion Criteria:

  • Hospitalized for COVID-19
  • Having received a treatment against COVID-19 (other than paracetamol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID+
Questionnaires on COVID-19 symptomatology and quality of life
Other: Questionnaires COVID+
  • 1 questionnaire on COVID-19 symptomatology and quality of life 12 months after COVID-19 first symptoms
  • 1 questionnaire on quality of life 18 months after COVID-19 first symptoms
COVID-
Questionnaires on quality of life
Other: Questionnaires COVID-
  • 1 questionnaire on quality of life at enrollment
  • 1 questionnaire on quality of life 6 months after enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term quality of life (mental component)
Time Frame: 18 months after COVID-19 first symptoms
Mental Component Score (MCS) of the SF-36 questionnaire. The MCS ranges from 0 (bad quality of life) to 100 (good quality of life).
18 months after COVID-19 first symptoms

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term quality of life (physical component)
Time Frame: 18 months after COVID-19 first symptoms
Physical Component Score (PCS) of the SF-36 questionnaire. The PCS ranges from 0 (bad quality of life) to 100 (good quality of life).
18 months after COVID-19 first symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

July 4, 2022

Study Completion (Actual)

July 4, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-COVID19-38
  • 2021-A01038-33 (Other Identifier: IDRCB)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Questionnaires COVID+

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe