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

COVID-19 Clinical Trial

— IMP@LA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200832
• Other study ID #: 2021PPRC06
• Secondary ID: 2021-A02623-38
• Status: Recruiting
• Start date: September 5, 2022
• Est. completion date: September 5, 2023

Study information

• Verified date: September 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Chrystel LAVAGNA
• Phone: 491637945
• Email: chrystel.lavagna-sevenier[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years-old

• Be affiliated to the French military health insurance

Exclusion Criteria:

• Age < 18 years-old

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre d'Epidémiologie et de Santé Publique des Armées	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of mental health events	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)