Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-04-22 @ 5:16 AM
Study NCT ID:
NCT05128695
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Public Health Consequences of Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}], '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': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longcovid', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly) (note that at baseline, also historical information is collected from the participants)', 'description': 'The symptoms that are defined by the WHO-definition of longcovid plus exploratory (data-driven--can include symptoms not in the current WHO-definition)'}, {'measure': 'Mental health', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly) (note that at baseline, also historical information is collected from the participants)', 'description': 'Negative health-outcomes related to mental health such as depression (assessed by PRQ9 scale)'}, {'measure': 'Social health', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly) (note that at baseline, also historical information is collected from the participants)', 'description': 'Negative health outcomes related to social health, such as loneliness (assessed by de Jong-Gierveld scale)'}, {'measure': 'Physical health', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly) (note that at baseline, also historical information is collected from the participants)', 'description': 'Negative health-outcomes related to physical health such as chronic non communicable disease (assessed upon self-report on a checklist of conditions present)'}, {'measure': 'Positive health and resilience', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)', 'description': 'Experienced general health (5-point scale ECHI)'}], 'secondaryOutcomes': [{'measure': 'Productivity', 'timeFrame': 'Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)', 'description': 'Socioeconomic impact on work and education (various scales)'}, {'measure': 'Adversity', 'timeFrame': 'change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)', 'description': 'Stigma and coping strategies related to Covid-19 adverse consequences'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Longcovid', 'Mental health', 'Loneliness', 'Depression', 'Fatigue', 'Social health', 'Care consumption', 'Public Health'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '37885796', 'type': 'DERIVED', 'citation': 'Pagen DME, van Bilsen CJA, Brinkhues S, Van Herck M, Konings K, den Heijer CDJ, Ter Waarbeek HLG, Spruit MA, Hoebe CJPA, Dukers-Muijrers NHTM. Prevalence of Long-term Symptoms Varies When Using Different Post-COVID-19 Definitions in Positively and Negatively Tested Adults: The PRIME Post-COVID Study. Open Forum Infect Dis. 2023 Sep 18;10(10):ofad471. doi: 10.1093/ofid/ofad471. eCollection 2023 Oct.'}, {'pmid': '36589958', 'type': 'DERIVED', 'citation': 'Pagen DME, van Bilsen CJA, Brinkhues S, Moonen CPB, Van Herck M, Konings K, den Heijer CDJ, Mujakovic S, Ter Waarbeek HLG, Bouwmeester-Vincken N, Vaes AW, Spruit MA, Hoebe CJPA, Dukers-Muijrers NHTM. Design and recruitment of a large-scale cohort study on prevalence, risk factors and impact evaluation of post-COVID-19 condition and its wider long-term social, mental, and physical health impact: The PRIME post-COVID study. Front Public Health. 2022 Dec 15;10:1032955. doi: 10.3389/fpubh.2022.1032955. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this observational study is to improve our understanding of the impact of Covid-19 on health. By an online questionnaire at least 60.000 people are invited by email to participate. Invited are those people who tested for Covid-19 at the Public Health Service South Limburg since June 2020. Participants are followed over time (open cohort), to study impact on health, that is physical health, mental health, and social health (longcovid and other conseauences). Also, the socioeconomic impact is studied, as on work and education. And the consequences for health-care consumption; it also includes aspects as coping, stigma and lifestyle. All focused to understand the impact of Covid-19, in relation to health, and to gain information for promoting positive health and improving prevention and care.', 'detailedDescription': 'Design: Prospective observational cohort study Mode of study: Online questionnaires Timing: Baseline starting nov. 2021; with regular follow-up measurements Measures: A great range of health-associated factors, all self-reported including a range of physical, mental and social health aspects.\n\nA range of structural and functional social netwok aspects Various measures on Covid-19 testing and vaccination Various measures on lifestyle behavior. And other measures that are interlinked with health-factors (such as coping, stress, and sociostructural factors) Analyses: Quantitative data are collected prospectively, and assessed using the appropriate data-analyses methods. Thee include for example epidemiological statistical methods, and social network methodology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults (aged 18+) who received a test for Covid-19 from the public health service south limburg from june 2020 onward, and who provided an email adress can be selected to be invited in this study.\n\nThis includes all people who tested positive. This includes a representative fraction (based on month of testing, age-group, sex, and region of residence) of those who tested negative.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Having recieved an online invitation to participate by an email with the study information and questionnaire link, which is send based on the email that was provided to the Public Health service upon testing for Covid-19 at the public health service south Limburg\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05128695', 'briefTitle': 'Public Health Consequences of Covid-19', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Public Health Service South Limburg'}, 'officialTitle': 'Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health', 'orgStudyIdInfo': {'id': '2021-2884'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid-19 positive', 'description': 'Adults who tested Covid-19 positive', 'interventionNames': ['Other: there is no intervention; the study is observational']}, {'label': 'Covid-19 negative', 'description': 'Adults who tested Covid-19 negative', 'interventionNames': ['Other: there is no intervention; the study is observational']}], 'interventions': [{'name': 'there is no intervention; the study is observational', 'type': 'OTHER', 'description': 'there is no intervention; the study is observational', 'armGroupLabels': ['Covid-19 negative', 'Covid-19 positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 2022, 6160 HA Geleen', 'city': 'Geleen', 'state': 'South Limburg', 'country': 'Netherlands', 'facility': 'Public Health Service South Limburg', 'geoPoint': {'lat': 50.97417, 'lon': 5.82917}}], 'overallOfficials': [{'name': 'Nicole Dukers-Muijrers, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Public Health Service South Limburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Coded data from this study will be made available for other researchers in due time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health Service South Limburg', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Maastricht University', 'class': 'OTHER'}, {'name': 'Center for Integrated Rehabilitation and Organ Failure Horn', 'class': 'OTHER'}, {'name': 'National Institute for Public Health and the Environment (RIVM)', 'class': 'OTHER_GOV'}, {'name': 'Public Health Service North Limburg, Netherlands', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior epidemiologist, associate professor', 'investigatorFullName': 'Nicole Dukers-Muijrers', 'investigatorAffiliation': 'Public Health Service South Limburg'}}}}