COVID-19IMP@LANCT05200832
Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
An observational study of COVID-19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Online questionnaire and Semi-structured interview
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 5 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years-old
- Be affiliated to the French military health insurance
Who cannot join
- Age < 18 years-old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Epidémiologie et de Santé Publique des Armées
Marseille, 13014
Chrystel LAVAGNA, 491637945945 ext. +33, chrystel.lavagna-sevenier@intradef.gouv.fr
Aurélie MAYET, MD, 491637989 ext. +33, aurelie.mayet@intradef.gouv.fr
About this study
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).
- Conditions
- COVID-19
- Being tested
- Online questionnaire, Semi-structured interview
- Keywords
- quality of life, long COVID
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Participants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic.
Semi-structured interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID+ | Participants who have experienced COVID-19 Receives: Other: Online questionnaire; Other: Semi-structured interview | |
| COVID- | Participants who have not experienced COVID-19 Receives: Other: Online questionnaire; Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Sep 2022
- Primary completion5 Sep 2023 (estimated)
- Study completion5 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200832
- Sponsor's protocol ID
- 2021PPRC06
- Other IDs
- 2021-A02623-38
- Acronym
- IMP@LA
- Status last verified
- Sep 2022
- First submitted
- 19 Jan 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
- ClinicalTrials.gov ID
- NCT05200832
- Acronym / sponsor ID
- IMP@LA / 2021PPRC06
- Conditions
- COVID-19
- Keywords
- quality of life, long COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID+ | – | Other: Online questionnaire, Other: Semi-structured interviewParticipants who have experienced COVID-19 |
| COVID- | – | Other: Online questionnaire, Other: Semi-structured interviewParticipants who have not experienced COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years-old
- Be affiliated to the French military health insurance
Key exclusion criteria (1 listed)
- Age < 18 years-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnaireParticipants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic. | Other | COVID+, COVID- |
| Semi-structured interview20 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. | Other | COVID+, COVID- |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chrystel LAVAGNA (491637945 ext. +33, chrystel.lavagna-sevenier@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mental health events (time frame: Until the end of the study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.