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临床试验/NCT04754308
NCT04754308已完成不适用

A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses

Hvidovre University Hospital12 个研究点 分布在 1 个国家目标入组 513 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
513
试验地点
12
主要终点
Prevalence of patients diagnosed with COPD after screening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Prevalence of patients diagnosed with COPD after screening

时间窗: Baseline

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

时间窗: Baseline

Distribution of diagnosed and undiagnoses COPD in patients

时间窗: Baseline

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

时间窗: 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?

时间窗: 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).

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

时间窗: Baseline

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Suppli Ulrik

Professor, consultant

Hvidovre University Hospital

研究点 (12)

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