Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-28 @ 3:46 PM
Study NCT ID:
NCT05200832
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2022-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of mental health events', 'timeFrame': 'Until the end of the study (12 months)', 'description': 'Prevalence of mental health events will be calculated in each group, the compared:\n\nnumber of participants who report having experienced a mental health event (e.g. anxiety disorder) divided by the number of participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'long COVID'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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%).\n\nThese 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years-old\n* Be affiliated to the French military health insurance\n\nExclusion Criteria:\n\n* Age \\< 18 years-old'}, 'identificationModule': {'nctId': 'NCT05200832', 'acronym': 'IMP@LA', 'briefTitle': 'Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families', 'orgStudyIdInfo': {'id': '2021PPRC06'}, 'secondaryIdInfos': [{'id': '2021-A02623-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID+', 'description': 'Participants who have experienced COVID-19', 'interventionNames': ['Other: Online questionnaire', 'Other: Semi-structured interview']}, {'label': 'COVID-', 'description': 'Participants who have not experienced COVID-19', 'interventionNames': ['Other: Online questionnaire', 'Other: Semi-structured interview']}], 'interventions': [{'name': 'Online questionnaire', 'type': 'OTHER', 'description': 'Participants will be asked to complete an online questionnaire about their health and quality of life since the start of the pandemic.', 'armGroupLabels': ['COVID+', 'COVID-']}, {'name': 'Semi-structured interview', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['COVID+', 'COVID-']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13014', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chrystel LAVAGNA', 'role': 'CONTACT', 'email': 'chrystel.lavagna-sevenier@intradef.gouv.fr', 'phone': '491637945945', 'phoneExt': '+33'}, {'name': 'Aurélie MAYET, MD', 'role': 'CONTACT', 'email': 'aurelie.mayet@intradef.gouv.fr', 'phone': '491637989', 'phoneExt': '+33'}], 'facility': "Centre d'Epidémiologie et de Santé Publique des Armées", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Chrystel LAVAGNA', 'role': 'CONTACT', 'email': 'chrystel.lavagna-sevenier@intradef.gouv.fr', 'phone': '491637945', 'phoneExt': '+33'}, {'name': 'Aurélie MAYET, MD', 'role': 'CONTACT', 'email': 'aurelie.mayet@intradef.gouv.fr', 'phone': '491637989', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}