- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128695
Public Health Consequences of Covid-19
Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
A 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
South Limburg
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Geleen, South Limburg, Netherlands, PO Box 2022, 6160 HA Geleen
- Public Health Service South Limburg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
This 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.
Description
Inclusion Criteria:
- 18 years of age or older
- 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
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Covid-19 positive
Adults who tested Covid-19 positive
|
there is no intervention; the study is observational
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Covid-19 negative
Adults who tested Covid-19 negative
|
there is no intervention; the study is observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longcovid
Time Frame: 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)
|
The symptoms that are defined by the WHO-definition of longcovid plus exploratory (data-driven--can include symptoms not in the current WHO-definition)
|
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)
|
Mental health
Time Frame: 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)
|
Negative health-outcomes related to mental health such as depression (assessed by PRQ9 scale)
|
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)
|
Social health
Time Frame: 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)
|
Negative health outcomes related to social health, such as loneliness (assessed by de Jong-Gierveld scale)
|
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)
|
Physical health
Time Frame: 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)
|
Negative health-outcomes related to physical health such as chronic non communicable disease (assessed upon self-report on a checklist of conditions present)
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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)
|
Positive health and resilience
Time Frame: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
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Experienced general health (5-point scale ECHI)
|
Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Productivity
Time Frame: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
|
Socioeconomic impact on work and education (various scales)
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Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
|
Adversity
Time Frame: change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
|
Stigma and coping strategies related to Covid-19 adverse consequences
|
change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Nicole Dukers-Muijrers, PhD, Public Health Service South Limburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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