Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families (IMP@LA)

September 12, 2022 updated by: Direction Centrale du Service de Santé des Armées

Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%).

These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care.

The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

14 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 will be composed of people affiliated to the French military health insurance, i.e., military Personnel (active or retired) and their families.

Description

Inclusion Criteria:

  • Age ≥ 18 years-old
  • Be affiliated to the French military health insurance

Exclusion Criteria:

  • Age < 18 years-old

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID+
Participants who have experienced COVID-19
Other: Online questionnaire
Participants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic.
Other: Semi-structured interview
20 participants (10 from each group) will be randomly selected to participate in a semi-structured interview focusing on their perception of their health and quality of life since the start of the pandemic.
COVID-
Participants who have not experienced COVID-19
Other: Online questionnaire
Participants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic.
Other: Semi-structured interview
20 participants (10 from each group) will be randomly selected to participate in a semi-structured interview focusing on their perception of their health and quality of life since the start of the pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of mental health events
Time Frame: Until the end of the study (12 months)

Prevalence of mental health events will be calculated in each group, the compared:

number of participants who report having experienced a mental health event (e.g. anxiety disorder) divided by the number of participants.
Until the end of the study (12 months)

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)

September 5, 2022

Primary Completion (Anticipated)

September 5, 2023

Study Completion (Anticipated)

September 5, 2023

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PPRC06
  • 2021-A02623-38 (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.

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