Clinical And Social Characteristics and Demographics in COPD

NCT02882165 | Completed

• 1 other identifier: 23464
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Early Intervention; Risk; Stratification

Outcome Measures

Primary Outcomes (1)

• COPD Assessment Test (CAT) score

  Validated measure of COPD symptom impact

  12 months

Secondary Outcomes (3)

• GAD-7 score

  12 months

• PHQ-9 score

  12 months

• EQ5D score

  12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Other: Medical review

Control arm

NO INTERVENTION

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

Interventions

Medical review OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southampton: lead
• National Institute for Health Research, United Kingdom: collaborator
• Collaboration for Leadership in Applied Health Research and Care (CLAHRC), UK: collaborator

Study Sites (1)

NIHR Wessex CLAHRC-Theme 1

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (20)

• British Thoracic Society. The Burden of Lung Disease, Statistics Report. British Thoracic Society, 2006

  BACKGROUND

• Office for National Statistics. Mortality Statistics: Deaths Registered in England and Wales (Series DR), 2013

  BACKGROUND

• Office for National Statistics. Death Registrations Summary Tables, England and Wales, 2013

  BACKGROUND

• Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: 2014

  BACKGROUND

• Cavailles 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.

  PMID: 24293462 BACKGROUND

• NHS England. An Outcomes Strategy for COPD and Asthma: NHS Companion Document. Department of Health 2012

  BACKGROUND

• Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.

  PMID: 18046898 BACKGROUND

• 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.

  PMID: 24600220 BACKGROUND

• Fletcher CM. Prognosis in chronic bronchitis. Aspen Emphysema Conf. 1968;9:309-15. No abstract available.

  PMID: 5722665 BACKGROUND

• 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.

  PMID: 22371650 BACKGROUND

• 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;2015(11):ED000107. doi: 10.1002/14651858.ED000107. No abstract available.

  PMID: 26593129 BACKGROUND

• 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. doi: 10.1002/14651858.CD001001.pub2.

  PMID: 17054132 BACKGROUND

• Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez 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. doi: 10.1136/thx.2005.040527. Epub 2005 Jul 29.

  PMID: 16055622 BACKGROUND

• Soler-Cataluna JJ, Martinez-Garcia MA, Sanchez LS, Tordera MP, Sanchez 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.

  PMID: 19131231 BACKGROUND

• Sin DD, Anthonisen NR, Soriano JB, Agusti AG. Mortality in COPD: Role of comorbidities. Eur Respir J. 2006 Dec;28(6):1245-57. doi: 10.1183/09031936.00133805.

  PMID: 17138679 BACKGROUND

• 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.

  PMID: 19797160 BACKGROUND

• 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. doi: 10.1056/NEJMoa021322.

  PMID: 14999112 BACKGROUND

• Sundh J, Janson C, Lisspers K, Stallberg 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.

  PMID: 22786813 BACKGROUND

• 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.

  PMID: 23538702 BACKGROUND

• 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.

  PMID: 23754870 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucy Rigge, BM BSc MRCP

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)