Clinical trial NCT05128695: Public Health Consequences of Covid-19
Official title: Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Keywords: Covid-19
Longcovid
Mental health
Loneliness
Depression
Fatigue
Social health
Care consumption
Public Health
Lead sponsor: Public Health Service South Limburg
Sponsor class: OTHER_GOV
Collaborators: name: Maastricht University
name: Center for Integrated Rehabilitation and Organ Failure Horn
name: National Institute for Public Health and the Environment (RIVM)
name: Public Health Service North Limburg, Netherlands
First posted: 2021-11-22
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
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)
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)
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)
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)
measure: Positive health and resilience
timeFrame: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Secondary outcomes:
measure: Productivity
timeFrame: Change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
measure: Adversity
timeFrame: change from the baseline questionaire up to 4 years thereafter, assessed at regular intervals (3,6,12 monthly)
Other outcomes:
Locations:
city: Geleen
country: Netherlands
facility: Public Health Service South Limburg
state: South Limburg
Study officials:
affiliation: Public Health Service South Limburg
name: Nicole Dukers-Muijrers, PhD
role: STUDY_CHAIR
References: