COPD and Socially Vulnerable Individuals

Hvidovre University Hospital

Status: Completed

Conditions: COPD

Treatments: Diagnostic Test: Spirometry

Study type: Interventional

Funder types: Other

Identifiers

NCT04754308

H-20031386

Details and patient eligibility

About

The trial investigates and describes the prevalence of COPD in patients who are in the social nurses' target group and investigates the effect of opportunistic screening for COPD in these vulnerable patients.

The study population is patients who have been referred to a social nurse at hospitals in the Capital Region, Central Denmark Region and Region Zealand of Denmark during the inclusion period, and monitor them for up to 5 years in order to investigate variables that are significant in terms of the patients' treatment, hospitalisations, and mortality in relation to COPD.

Our hypothesis is that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.

Full 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", 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.

Enrollment: 513 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Able to speak and understand Danish to such an extent that informed consent can be obtained

Exclusion criteria

• Not having a Danish civil registration number, since foreign patients do not have free access to examinations and medical treatment, and cannot be followed up in the national patient registry

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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513 participants in 1 patient group

Patients referred to social nurse

Other group

Description:

After obtaining informed consent, the social nurse reviews the online-questionnaire with the patient and performs a lung function examination requiring the patient to blow into a plastic tube. If a patient is identified as having obstructive reduction of lung function, they are offered a referral to a local pulmonary medicine department or GP for further investigation - regardless of whether or not they have a diagnosed or undiagnosed lung disease. In addition, participants are questioned about their motivation for smoking cessation and are informed of the options for this (in hospital and/or referral to the municipality).

Treatment:

Diagnostic Test: Spirometry