COPD and Socially Vulnerable Individuals

NCT04754308 | Completed DMC

• 1 other identifier: H-20031386
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 10

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.

Conditions

COPD

Keywords

Screening; Socially vulnerable patients; Social nurses

Outcome Measures

Primary Outcomes (6)

• Prevalence of obstructive lung function reduction in patients in the social nurses' target group

  Baseline

• Distribution of diagnosed and undiagnoses COPD in patients

  Baseline

• Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP

  Baseline

• Prevalence of patients diagnosed with COPD after screening

  Baseline

• Does opportunistic screening by social nurses impact on the number of hospital visits?

  The outcome is number of outpatient and acute visits with a-diagnosis related to COPD for 3 groups of patients: The group with undiagnosed COPD at inclusion who were investigated, and the group with undiagnosed COPD at inclusion who did not want investigation compared with the group of patients with already diagnosed COPD at inclusion (control group).

  Follow-up 5 years from inclusion

• Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD?

  The outcome is redeemed prescriptions for COPD medication among the 2 groups of patients: The group with undiagnosed COPD at inclusion compared with the group of patients with already diagnosed COPD at inclusion (control group).

  Follow-up 5 years from inclusion

Secondary Outcomes (3)

• Prevalence of patients who smoke and wish to stop smoking

  Baseline

• Prevalence of patients with impaired lung function who have a desire to stop smoking

  Baseline

• Prevalence of patients who want to quit smoking and accept the smoking cessation offers.

  Baseline

Study Arms (1)

Patients referred to social nurse

OTHER

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).

Diagnostic Test: Spirometry

Interventions

Spirometry DIAGNOSTIC_TEST

The method of examination, Spirometry, is non-invasive (i.e. not an intervention that involves penetration into the body by means of incisions or injections.). It is a routine examination and there are no risks, adverse reactions, or discomforts associated with the examination.

Patients referred to social nurse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Aarhus University Hospital: collaborator
• REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care: collaborator

Study Sites (10)

Århus Universitetshospital

Aarhus, Denmark

Location

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

Location

Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

Location

Herlev and Gentofte Hospital

Copenhagen, Denmark

Location

Regionshospitalet Horsens

Horsens, Denmark

Location

Hvidovre Hospital

Hvidovre, 2765, Denmark

Location

Sjællands Universitetshospital Køge og Roskilde

Køge, Denmark

Location

Nykøbing Falster Sygehus

Nykøbing Falster, Denmark

Location

Bornholm Hospital

Rønne, Denmark

Location

Næstved-Slagelse-Ringsted Hospital

Slagelse, Denmark

Location

Related Publications (1)

• Brunes N, Lindstroem MB, Ulrik CS, Andersen O, Lisby M, Godtfredsen NS, Hansen TL, Pisinger C, Graven V, Marsaa K, Thomsen LH. Opportunistic screening for COPD among socially marginalized patients. BMC Pulm Med. 2024 Mar 5;24(1):113. doi: 10.1186/s12890-024-02927-9.

  PMID: 38443835 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nina Brünés

  Amager and Hvidovre Hospital, Patientforloeb

  STUDY CHAIR

• Charlotte Ulrik

  Amager and Hvidovre Hospital, Medical Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: April 19, 2021
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (10)