Clinical trial NCT04754308: COPD and Socially Vulnerable Individuals
Official title: A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Screening
Socially vulnerable patients
Social nurses
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
First posted: 2021-02-15
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of obstructive lung function reduction in patients in the social nurses' target group
timeFrame: Baseline
measure: Distribution of diagnosed and undiagnoses COPD in patients
timeFrame: Baseline
measure: Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
timeFrame: Baseline
measure: Prevalence of patients diagnosed with COPD after screening
timeFrame: Baseline
measure: Does opportunistic screening by social nurses impact on the number of hospital visits?
timeFrame: Follow-up 5 years from inclusion
measure: Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD?
timeFrame: Follow-up 5 years from inclusion
Secondary outcomes:
measure: Prevalence of patients who smoke and wish to stop smoking
timeFrame: Baseline
measure: Prevalence of patients with impaired lung function who have a desire to stop smoking
timeFrame: Baseline
measure: Prevalence of patients who want to quit smoking and accept the smoking cessation offers.
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
city: Horsens
country: Denmark
facility: Regionshospitalet Horsens
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Køge
country: Denmark
facility: Sjællands Universitetshospital Køge og Roskilde
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster Sygehus
city: Rønne
country: Denmark
facility: Bornholm Hospital
city: Slagelse
country: Denmark
facility: Næstved-Slagelse-Ringsted Hospital
city: Århus
country: Denmark
facility: Århus Universitetshospital
Study officials:
affiliation: Amager and Hvidovre Hospital, Patientforloeb
name: Nina Brünés
role: STUDY_CHAIR
affiliation: Amager and Hvidovre Hospital, Medical Department
name: Charlotte Ulrik
role: PRINCIPAL_INVESTIGATOR
References: