Clinical And Social Characteristics and Demographics in COPD (CASCADE)
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|ClinicalTrials.gov Identifier: NCT02882165|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2016
Last Update Posted : May 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Medical review||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Quantitative Study in Early Chronic Obstructive Pulmonary Disease, Using a Cluster Analysis, to Establish if Prospective, Individualised, Medical Intervention Alters Projected Clinical Course|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||August 2018|
Experimental: Intervention arm
Participants receive a comprehensive medical review by a Respiratory Clinical Fellow.
Other: Medical review
A personalised, medical review will be conducted by a respiratory-trained Clinical Fellow. The Clinical Fellow will address any changes needed to optimise their lung health, any comorbidities and social situation. Education will be provided with regards to the COPD diagnosis, identifying and treating exacerbations, inhaler technique, smoking cessation and nutrition. The review will ensure any secondary prevention needs have been addressed and suggest onward referral to other services in primary or secondary care as the patient requires.
A follow up appointment will be booked during the initial appointment; to take place four to eight weeks later to identify and act upon any new clinical issues relevant to the patient's COPD and to follow up any clinical issues previously identified
No Intervention: Control arm
Participants receive usual care as required via their primary care practice.
- COPD Assessment Test (CAT) score [ Time Frame: 12 months ]Validated measure of COPD symptom impact
- GAD-7 score [ Time Frame: 12 months ]Validated measure of symptoms of anxiety impact on life
- PHQ-9 score [ Time Frame: 12 months ]Validated measure of symptoms of depression impact on life
- EQ5D score [ Time Frame: 12 months ]Validated measure of quality of life
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): NCT02882165
|NIHR Wessex CLAHRC-Theme 1|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator:||Lucy Rigge, BM BSc MRCP||University of Southampton|