Public Health Consequences of Covid-19

COVID-19 Clinical Trial

Official title:

Long-term Public Health Consequences of Covid-19-- Physical, Mental and Social Health

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05128695
• Other study ID #: 2021-2884
• Status: Enrolling by invitation
• Start date: November 17, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2021
• Source: Public Health Service South Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• there is no intervention; the study is observational
there is no intervention; the study is observational

Locations

Country	Name	City	State
Netherlands	Public Health Service South Limburg	Geleen	South Limburg

Sponsors (5)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Productivity	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)
Secondary	Adversity	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)