Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
COPD
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study consists of two sub-studies: A a descriptive cross-sectional study "The prevalence of COPD in patients who are in the social nurses' target group" followed by study B a cohort study "The effect of opportunistic screening for COPD in patients who are in the social nurses' target group", bas...

The study consists of two sub-studies: A a descriptive cross-sectional study "The prevalence of COPD in patients who are in the social nurses' target group" followed by study B a cohort study "The effect of opportunistic screening for COPD in patients who are in the social nurses' target group", based on a closed cohort. People in the lower social classes are at increased risk of developing COPD due to their lifelong accumulation of risk factors, such as smoking, passive smoking and the influence of lifestyle and the environment. In the group with the socially vulnerable individuals, 70% are smokers compared to 18% in the general Danish population. The socially vulnerable individuals are defined here as people affected by homelessness, drug abuse, harmful alcohol consumption, mental illness and poverty. Despite the socially vulnerable group having an over-consumption of general practice visits, 25% of the patients in the social nurses' target group state that they do not have contact with or use their own doctor. Our hypothesis is therefore that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population. Purpose: To investigate and describe the prevalence of COPD in patients who are in the social nurses' target group and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens. Data collection: Baseline data from the cross-sectional study are derived from lung function measurement and REDCap online-questionnaires completed on inclusion. The data from the cohort study regarding disease burden and hospital visits originates from the national patient registry (LPR) and mortality data is retrieved from the Danish Register of Causes of Death. Data regarding redeemed prescriptions for COPD medicine originates from the Prescription Database. The patients' connection to the job market and income status are based on extracts from RAS (Registry-based Labour Force Statistics), which is administered by Statistics Denmark. Data regarding the highest acquired education (HFAUDD) is from Statistics Denmark. Variables: There will be collected the following variables at inclusion: information on demographics, lung function, selv-reported information on: risk factors, socioeconomic variables and symptoms of lung disease. Moreover register data on socioeconomic status, morbidity, physical health by Charlson score, mortality, hospital visits and prescriptions for COPD Medicine will be retrieved after 5 years follow-up. Sample size: To detect a difference between the patient group and the Danish population of minimum 100% a total of 511 participants are needed in the study (power of 80%, p-values=0,05, an estimated COPD prevalence of 4,3% in the Danish population). The collected data will be kept in accordance to the Data Protection Agency guidelines. The studies are carried out in accordance with the principles of the Helsinki Declaration.

Tracking Information

NCT #
NCT04754308
Collaborators
  • Copenhagen University Hospital at Herlev
  • Frederiksberg University Hospital
  • Aarhus University Hospital
Investigators
Study Chair: Nina Brünés Amager and Hvidovre Hospital, Patientforloeb Principal Investigator: Charlotte Ulrik Amager and Hvidovre Hospital, Medical Department