Public Health Consequences of Covid-19

November 18, 2021 updated by: Nicole Dukers-Muijrers, Public Health Service South Limburg

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.

Study Overview

Status

Enrolling by invitation

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

Observational

Enrollment (Anticipated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South Limburg
      • Geleen, South Limburg, Netherlands, PO Box 2022, 6160 HA Geleen
        • Public Health Service South Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19 positive
Adults who tested Covid-19 positive
Other: there is no intervention; the study is observational
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
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)
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)
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Service South Limburg

Collaborators

Maastricht University
National Institute for Public Health and the Environment (RIVM)
Center for Integrated Rehabilitation and Organ Failure Horn
Public Health Service North Limburg, Netherlands

Investigators

  • Study Chair: Nicole Dukers-Muijrers, PhD, Public Health Service South Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

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)?

UNDECIDED

IPD Plan Description

Coded data from this study will be made available for other researchers in due time

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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