COVID-19NCT05128695
Public Health Consequences of Covid-19
An observational study of COVID-19, run by Public Health Service South Limburg at 1 site in Netherlands.
Trial summary
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. 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
- How many people
- 60,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2021to 1 Dec 2025
- 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: 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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Public Health Service South Limburg
Geleen, South Limburg, PO Box 2022, 6160 HA Geleen
About this study
Official title: Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- there is no intervention; the study is observational
- Keywords
- Covid-19, Longcovid, Mental health, Loneliness, Depression, Fatigue, Social health, Care consumption, Public Health
- Medical subject headings
- COVID-19, Psychological Well-Being, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no intervention; the study is observationalOther
there is no intervention; the study is observational
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 positive | Adults who tested Covid-19 positive Receives: Other: there is no intervention; the study is observational | |
| Covid-19 negative | Adults who tested Covid-19 negative Receives: Other: there is no intervention; the study is observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longcovid
The symptoms that are defined by the WHO-definition of longcovid plus exploratory (data-driven--can include symptoms not in the current WHO-definition)
Measured: 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
Negative health-outcomes related to mental health such as depression (assessed by PRQ9 scale)
Measured: 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
Negative health outcomes related to social health, such as loneliness (assessed by de Jong-Gierveld scale)
Measured: 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
Negative health-outcomes related to physical health such as chronic non communicable disease (assessed upon self-report on a checklist of conditions present)
Measured: 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
Experienced general health (5-point scale ECHI)
Measured: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Secondary outcomes (2)
Productivity
Socioeconomic impact on work and education (various scales)
Measured: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Adversity
Stigma and coping strategies related to Covid-19 adverse consequences
Measured: change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start17 Nov 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Service South Limburg
- Sponsor type
- Other government
- Collaborators
- Maastricht University, Center for Integrated Rehabilitation and Organ Failure Horn, National Institute for Public Health and the Environment (RIVM), Public Health Service North Limburg, Netherlands
- Responsible party
- Principal investigator, Nicole Dukers-Muijrers, Public Health Service South Limburg
- Investigators
- Nicole Dukers-Muijrers, PhD, Study chair, Public Health Service South Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128695
- Sponsor's protocol ID
- 2021-2884
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Coded data from this study will be made available for other researchers in due time
Publications
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.
PubMed 37885796Pagen 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.
PubMed 36589958
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health
- ClinicalTrials.gov ID
- NCT05128695
- Acronym / sponsor ID
- 2021-2884
- Conditions
- COVID-19
- Keywords
- Covid-19, Longcovid, Mental health, Loneliness, Depression, Fatigue, Social health, Care consumption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Public Health Service South LimburgOther government
- Collaborators
- Maastricht University, Center for Integrated Rehabilitation and Organ Failure Horn, National Institute for Public Health and the Environment (RIVM), Public Health Service North Limburg, Netherlands
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Nov 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 positive | – | Other: there is no intervention; the study is observationalAdults who tested Covid-19 positive |
| Covid-19 negative | – | Other: there is no intervention; the study is observationalAdults who tested Covid-19 negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| there is no intervention; the study is observationalthere is no intervention; the study is observational | Other | Covid-19 negative, Covid-19 positive |
Primary outcome
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)
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)
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)
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)
Positive health and resilience
Time frame: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Experienced general health (5-point scale ECHI)
2 secondary outcomes
Productivity
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 37885796Pagen 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.
- Derived from this study: PubMed 36589958Pagen 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.
- Individual participant dataSharing planned: Undecided. Coded data from this study will be made available for other researchers in due time
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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.
Nicole Dukers-Muijrers, PhD study chair
Public Health Service South Limburg
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 Public Health Service South Limburg at 1 site in Netherlands.
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 22 Nov 2021. 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 Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128695, which also lists 2 linked publications.
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 22 Nov 2021.