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临床试验/NCT02882165
NCT02882165已完成不适用

A Quantitative Study in Early Chronic Obstructive Pulmonary Disease, Using a Cluster Analysis, to Establish if Prospective, Individualised, Medical Intervention Alters Projected Clinical Course

University of Southampton1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1
主要终点
COPD Assessment Test (CAT) score

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally induced lung damage e.g. cigarette smoking and air pollution which, over time, causes individuals to suffer from symptoms including chronic cough and progressive breathlessness. In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades before the symptoms appear and the disease is diagnosed.

The aim of this study is to identify those COPD patients who currently have milder disease and to investigate whether a detailed, medical assessment which has time to assess all aspects of their care will improve their lung health and general wellbeing.

COPD is a major cause of disability and death in the UK, with around 835,000 people currently diagnosed with the disease and an estimated further two million people who suffer from symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die from COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in England and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes an enormous symptom burden to patients, and accounts for up to half of emergency admissions to already overstretched hospital services in England (4).

People with COPD, with a past history of smoking, are at higher risk of other medical problems such as heart disease and stroke(5). Being breathless and having multiple physical health problems can also lead to mental health problems such as anxiety and depression(5). This means it can be challenging to provide this group of people enough time to fully assess and treat all their problems, particularly due to current pressure on the length of GP appointment times.

Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and intervention provided a key part of the strategy for COPD published by NHS England in 2012(6). With early diagnosis, the opportunity is provided to intervene with the aim of improving symptoms and exercise tolerance, reducing the risk of exacerbations, slowing deterioration and prolonging quality of life.

详细描述

  1. Background

1.1: History and Burden of COPD Chronic Obstructive Pulmonary Disease (COPD) is believed to have been first described by Theophile Bonnet in 1679 in the form of cadaveric 'voluminous lungs'(7). Despite being a major cause of disability and death in the UK(1), COPD still remains a relatively poor relation to many of the other current leading causes of death in terms of health resource allocation, patient and public understanding and the interest and motivation of health professionals to diagnose and manage the disease(8). Over the last three hundred years, COPD has been known to health professionals and the public in a variety of guises including emphysema, chronic bronchitis, smoker's cough and chronic airflow obstruction. The term, Chronic Obstructive Pulmonary Disease is believed to have been used for the first time in 1965 by William Briscoe at the 9th Aspen Emphysema Conference(7). Although the name has now been successfully unified, the negative associations, variable diagnosis rates and management strategies amongst patients with the disease continue. Sadly, a nihilistic attitude towards the value of diagnosis and treatment of the disease is still found in some clinicians, with some feeling the value of accurate and early diagnosis is small as there is no evidence for any disease course altering interventions(8). Whilst there are a lack of disease-modifying interventions other than smoking cessation, there are effective pharmacological and non-pharmacological interventions that have been shown to improve disease symptoms(4). Accurate, early diagnosis and disease education are the first steps to achieving high quality care throughout the whole patient journey up to and including palliative care.

COPD patients may be perceived as either being on a slow emphysematous downward decline or, to spiral rapidly through the cycle of recurrent exacerbations and hospital admissions to lung function decline and death (8-10). However, with the range of effective interventions now available (including pharmacological strategies, patient education, diet and exercise strategies, vaccination and targeted smoking cessation interventions) early diagnosis and ongoing proactive care should be the 'gold standard'(4).

The relatively recent evidence supporting pulmonary rehabilitation(11), lung volume reduction techniques(12), and modern developments in pharmacotherapy and preventative care have provided health care professionals with access to therapies which have proven benefits in terms of morbidity. The wealth of inhaled therapies flooding the market and the enormous cost burden of COPD to the NHS has led to more interest and research in the disease in the last decade. This research has generated an increased understanding of disease pathology, recognition of multiple disease phenotypes and the growing acknowledgement of the need to direct therapies to individuals rather than the disease population as a whole.

Increasing bed pressures in the NHS has shifted focus towards identification of those high-risk patients who are recurrent hospital attendees, and resources have been directed towards strategies to reduce hospitalisation and towards community based care. Currently, services vary enormously between hospital trusts and commissioning groups, ranging from Community Matron support, hospital admission avoidance and early discharge schemes, to full time, multidisciplinary, integrated COPD teams all of which are attempting to bridge the gap in service provision and communication between Primary and Secondary Care(4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •Already on primary care COPD register and DOSE score <4 (low risk)

排除标准

  • •No capacity to consent or unable to travel to primary care practice (local GP surgery)

研究组 & 干预措施

Intervention arm

Experimental

Participants receive a comprehensive medical review by a Respiratory Clinical Fellow.

干预措施: Medical review (Other)

Control arm

No Intervention

Participants receive usual care as required via their primary care practice.

结局指标

主要结局

COPD Assessment Test (CAT) score

时间窗: 12 months

Validated measure of COPD symptom impact

次要结局

  • GAD-7 score(12 months)
  • PHQ-9 score(12 months)
  • EQ5D score(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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