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

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05200832
Collaborator
(none)
10,000
1
12
833.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Online questionnaire
  • Other: Semi-structured interview

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of mental health events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age ≥ 18 years-old

  • Be affiliated to the French military health insurance

Exclusion Criteria:
  • Age < 18 years-old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre d'Epidémiologie et de Santé Publique des Armées Marseille France 13014

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT05200832
Other Study ID Numbers:
  • 2021PPRC06
  • 2021-A02623-38
First Posted:
Jan 21, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
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 Direction Centrale du Service de Santé des Armées
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022