COPD and Socially Vulnerable Individuals
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| ClinicalTrials.gov Identifier: NCT04754308 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2021
Last Update Posted : August 31, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD | Diagnostic Test: Spirometry | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 511 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses |
| Actual Study Start Date : | April 19, 2021 |
| Estimated Primary Completion Date : | September 1, 2026 |
| Estimated Study Completion Date : | September 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Patients referred to social nurse
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
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. |
- Prevalence of obstructive lung function reduction in patients in the social nurses' target group [ Time Frame: Baseline ]
- Distribution of diagnosed and undiagnoses COPD in patients [ Time Frame: Baseline ]
- Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP [ Time Frame: Baseline ]
- Prevalence of patients diagnosed with COPD after screening [ Time Frame: Baseline ]
- Does opportunistic screening by social nurses impact on the number of hospital visits? [ Time Frame: Follow-up 5 years from inclusion ]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).
- Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD? [ Time Frame: Follow-up 5 years from inclusion ]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).
- Prevalence of patients who smoke and wish to stop smoking [ Time Frame: Baseline ]
- Prevalence of patients with impaired lung function who have a desire to stop smoking [ Time Frame: Baseline ]
- Prevalence of patients who want to quit smoking and accept the smoking cessation offers. [ Time Frame: Baseline ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754308
| Contact: Mette Lindstroem | +4538623308 | mette.bendtz.lindstroem@regionh.dk | |
| Contact: Ove Andersen | +4529333262 | ove.andersen@regionh.dk |
| Denmark | |
| Bispebjerg and Frederiksberg Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Helle F Andreassen +45 38636177 | |
| Copenhagen University Hospital Rigshospitalet | Recruiting |
| Copenhagen, Denmark | |
| Contact: Charlotte Ulrik +45 38626089 charlotte.suppli.ulrik@regionh.dk | |
| Herlev and Gentofte Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Vibeke Gottlieb +45 38672115 vibeke.gottlieb.02@regionh.dk | |
| Nordsjælland Hospital | Withdrawn |
| Hillerød, Denmark | |
| Regionshospitalet Horsens | Recruiting |
| Horsens, Denmark | |
| Contact: Thomas Hahn +45 78426651 thomas.hahn@horsens.rm.dk | |
| Hvidovre Hospital | Recruiting |
| Hvidovre, Denmark, 2765 | |
| Contact: Charlotte Ulrik, Prof. +45 38626089 charlotte.suppli.ulrik@regionh.dk | |
| Sjællands Universitetshospital Køge og Roskilde | Recruiting |
| Køge, Denmark | |
| Contact: Poul Mossin +45 30459562 pmoi@regionsjaelland.dk | |
| Nykøbing Falster Sygehus | Recruiting |
| Nykøbing Falster, Denmark | |
| Contact: Christian Christiansen +45 56515016 chchris@regionsjaelland.dk | |
| Bornholm Hospital | Recruiting |
| Rønne, Denmark | |
| Contact: Diana U Kaiser 38671878 diana.utech.kaiser.01@regionh.dk | |
| Næstved-Slagelse-Ringsted Hospital | Recruiting |
| Slagelse, Denmark | |
| Contact: Uffe Bødtger +45 56513140 ubt@regionsjaelland.dk | |
| Århus Universitetshospital | Recruiting |
| Århus, Denmark | |
| Contact: Pernille Hauschildt +78462076 pernhaus@rm.dk | |
| Study Chair: | Nina Brünés | Amager and Hvidovre Hospital, Patientforloeb | |
| Principal Investigator: | Charlotte Ulrik | Amager and Hvidovre Hospital, Medical Department |
| Responsible Party: | Charlotte Suppli Ulrik, Professor, consultant, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT04754308 |
| Other Study ID Numbers: |
H-20031386 |
| First Posted: | February 15, 2021 Key Record Dates |
| Last Update Posted: | August 31, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Screening Socially vulnerable patients Social nurses |