NCT05128695

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

4 years

First QC Date

November 17, 2021

Last Update Submit

November 18, 2021

Conditions

COVID-19

Keywords

Covid-19LongcovidMental healthLonelinessDepressionFatigueSocial healthCare consumptionPublic Health

Outcome Measures

Primary Outcomes (5)

  • 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)

    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)

    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)

    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)

    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)

    Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)

Secondary Outcomes (2)

  • Productivity

    Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)

  • Adversity

    change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)

Study Arms (2)

Covid-19 positive

Adults who tested Covid-19 positive

Other: there is no intervention; the study is observational

Covid-19 negative

Adults who tested Covid-19 negative

Other: there is no intervention; the study is observational

Interventions

there is no intervention; the study is observationalOTHER

there is no intervention; the study is observational

Covid-19 negativeCovid-19 positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Service South Limburg

Geleen, South Limburg, PO Box 2022, 6160 HA Geleen, Netherlands

Location

Related Publications (2)

  • 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: 37885796DERIVED

  • 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.

    PMID: 36589958DERIVED

MeSH Terms

Conditions

COVID-19Psychological Well-BeingDepressionFatigue

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehaviorBehavioral SymptomsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Dukers-Muijrers, PhD

    Public Health Service South Limburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior epidemiologist, associate professor

Study Record Dates

First Submitted

November 17, 2021

First Posted

November 22, 2021

Study Start

November 17, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

NL(1)