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Clinical And Social Characteristics and Demographics in COPD (CASCADE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02882165
First Posted: August 29, 2016
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute for Health Research, United Kingdom
Collaboration for Leadership in Applied Health Research and Care (CLAHRC), UK
Information provided by (Responsible Party):
University of Southampton
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease Other: Medical review

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • COPD Assessment Test (CAT) score [ Time Frame: 12 months ]
    Validated measure of COPD symptom impact


Secondary Outcome Measures:
  • 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


Enrollment: 116
Study Start Date: July 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No capacity to consent or unable to travel to primary care practice (local GP surgery)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
NIHR Wessex CLAHRC-Theme 1
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Southampton
National Institute for Health Research, United Kingdom
Collaboration for Leadership in Applied Health Research and Care (CLAHRC), UK
Investigators
Principal Investigator: Lucy Rigge, BM BSc MRCP University of Southampton
  More Information

Publications:
British Thoracic Society. The Burden of Lung Disease, Statistics Report. British Thoracic Society, 2006
Office for National Statistics. Mortality Statistics: Deaths Registered in England and Wales (Series DR), 2013
Office for National Statistics. Death Registrations Summary Tables, England and Wales, 2013
Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. Epub 2007 May 16. Review.
Cavaillès A, Brinchault-Rabin G, Dixmier A, Goupil F, Gut-Gobert C, Marchand-Adam S, Meurice JC, Morel H, Person-Tacnet C, Leroyer C, Diot P. Comorbidities of COPD. Eur Respir Rev. 2013 Dec;22(130):454-75. doi: 10.1183/09059180.00008612. Review.
NHS England. An Outcomes Strategy for COPD and Asthma: NHS Companion Document. Department of Health 2012
Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. Review.
Csikesz NG, Gartman EJ. New developments in the assessment of COPD: early diagnosis is key. Int J Chron Obstruct Pulmon Dis. 2014 Feb 27;9:277-86. doi: 10.2147/COPD.S46198. eCollection 2014. Review.
Fletcher CM. Prognosis in chronic bronchitis. Aspen Emphysema Conf. 1968;9:309-15.
Tantucci C, Modina D. Lung function decline in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:95-9. doi: 10.2147/COPD.S27480. Epub 2012 Feb 9. Review.
Lacasse Y, Cates CJ, McCarthy B, Welsh EJ. This Cochrane Review is closed: deciding what constitutes enough research and where next for pulmonary rehabilitation in COPD. Cochrane Database Syst Rev. 2015 Nov 18;(11):ED000107. doi: 10.1002/14651858.ED000107.
Tiong LU, Davies R, Gibson PG, Hensley MJ, Hepworth R, Lasserson TJ, Smith B. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001001. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 14;10 :CD001001.
Soler-Cataluña JJ, Martínez-García MA, Román Sánchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov;60(11):925-31. Epub 2005 Jul 29.
Soler-Cataluña JJ, Martínez-García MA, Sánchez LS, Tordera MP, Sánchez PR. Severe exacerbations and BODE index: two independent risk factors for death in male COPD patients. Respir Med. 2009 May;103(5):692-9. doi: 10.1016/j.rmed.2008.12.005. Epub 2009 Jan 7.
Sin DD, Anthonisen NR, Soriano JB, Agusti AG. Mortality in COPD: Role of comorbidities. Eur Respir J. 2006 Dec;28(6):1245-57. Review.
Jones RC, Donaldson GC, Chavannes NH, Kida K, Dickson-Spillmann M, Harding S, Wedzicha JA, Price D, Hyland ME. Derivation and validation of a composite index of severity in chronic obstructive pulmonary disease: the DOSE Index. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1189-95. doi: 10.1164/rccm.200902-0271OC. Epub 2009 Sep 24.
Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12.
Sundh J, Janson C, Lisspers K, Ställberg B, Montgomery S. The Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) index is predictive of mortality in COPD. Prim Care Respir J. 2012 Sep;21(3):295-301. doi: 10.4104/pcrj.2012.00054.
Rolink M, van Dijk W, van den Haak-Rongen S, Pieters W, Schermer T, van den Bemt L. Using the DOSE index to predict changes in health status of patients with COPD: a prospective cohort study. Prim Care Respir J. 2013 Jun;22(2):169-74. doi: 10.4104/pcrj.2013.00033.
Motegi T, Jones RC, Ishii T, Hattori K, Kusunoki Y, Furutate R, Yamada K, Gemma A, Kida K. A comparison of three multidimensional indices of COPD severity as predictors of future exacerbations. Int J Chron Obstruct Pulmon Dis. 2013;8:259-71. doi: 10.2147/COPD.S42769. Epub 2013 May 31.

Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT02882165     History of Changes
Other Study ID Numbers: 23464
First Submitted: August 24, 2016
First Posted: August 29, 2016
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Southampton:
COPD
Early Intervention
Risk
Stratification

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


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