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Trial registered on ANZCTR

Registration number

ACTRN12612000514808

Ethics application status

Approved

Date submitted

10/05/2012

Date registered

15/05/2012

Date last updated

1/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.

Scientific title

The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1130-0242

Trial acronym

COPE-III

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COPD

ischaemic heart disease

chronic heart failure

diabetes mellitus I

diabetes mellitus II

anxiety

depression

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Cardiovascular

Coronary heart disease

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A COPD self-treatment approach for COPD patients with multiple diseases. The intervention group patients will learn to treat their COPD exacerbations and/or flare-ups of comorbidities with the help of an action plan linked to a daily symptom diary, which they will be asked to complete for a 12-month period. The self-treatment training starts after inclusion and consists of 4 sessions which are guided by the trial nurses: two 2.5-hour group sessions at week 1 and 3 and two individual 1.5-hour sessions at week 2 and 4. Besides self-treatment, the program will be aimed at knowledge about COPD and comorbidities, immunisations, inhaler techniques, physical fitness, relaxation and breathing exercises. One, four, and eight months after completion of the training, the trial nurse will contact the patient by phone, to reinforce self-management skills. Trial nurse act as case-managers throughout the study.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

Control patients will receive two 30-minute group meetings held on two consecutive weeks (week 1 and 2) during which they will be trained in diary use. Control patients will be asked to complete the daily symptoms diaries for the whole study-period (12 months), to mail the completed diaries back to the study office, and to continue with their usual care providers when they need assistance for any worsening of their respiratory or other symptoms. In lieu of the self-management sessions and follow-up phone calls provided to the intervention group, these control subjects will receive five phone calls that will only provide questions and feedback regarding the diaries: in week 3, 4, 8, 20 and 36.

Control group

Active

Outcomes

Primary outcome [1]

Number of COPD exacerbation days measured by daily symptom diary.

The start of the exacerbation will be defined as a clear negative change from baseline in at least two major symptoms (sputum color, sputum production, breathlessness) or one major and one minor symptom (coughing, wheezing, fever) from baseline, for at least two consecutive days. The day that the exacerbation is resolved will be defined as the first day of: 1) three successive days that the patient has returned to his normal health state; or 2) seven consecutive days on which patients continuously report no or only a slight increase in
symptoms compared to baseline, with no fever or change in sputum colour.

Timepoint [1]

Over a 12-month period

Secondary outcome [1]

Health care utilisations for COPD, all cause respiratory, cardiac and diabetes: GP visits, specialist consultations and other services, number of hospitalizations, number of in-hospital days, number of emergency hospital presentations, number of days spent in intensive care facility.

Australia: data on the frequency and duration of hospital emergency department, in-patient admissions and out-patient activity will be obtained from medical records, and PBS and MBS utilisation data will be sought from Medicare to evaluate cost-effectiveness (following patient or proxy consent).

Netherlands: For economic analysis, data regarding health care resource use (e.g. out-patient visits, hospitalisations and GP visits) will be retrospectively collected for all patients using the hospital and GP databases. Medication details for all patients will be retrospectively collected from the pharmacists.

Timepoint [1]

Over a 12-month period

Secondary outcome [2]

Exacerbation severity of COPD and chronic heart failure (daily symptom diary): number of symptom-based exacerbations, severity of symptom scores; number of chronic heart failure exacerbation days.

Timepoint [2]

Over a 12 month period

Secondary outcome [3]

Dyspnoe (mMRC dyspnoea scale)

Timepoint [3]

Baseline, 6 and 12 months

Secondary outcome [4]

Health-related Quality of Life (Chronic Respiratory Questionnaire; CRQ)

Timepoint [4]

Baseline, 6 and 12 months

Secondary outcome [5]

Fatigue (Identity-Consequences Fatigue Scale)

Timepoint [5]

Baseline, 6 and 12 months

Secondary outcome [6]

Anxiety and depression symptoms (Hospital Anxiety and Depression Scale; HADS);

Timepoint [6]

Baseline, 6 and 12 months

Secondary outcome [7]

Health-related quality of life (EuroQol 5D);

Timepoint [7]

Baseline, 6 and 12 months

Secondary outcome [8]

Spirometry (FEV1, FEV6, FVC)

Timepoint [8]

Baseline and 12 months

Secondary outcome [9]

Adherence of patients with the self-treatment protocol will be retrospectively determined from the daily diary (number of days between start of exacerbation/flare-up of comorbidity and the initiation of the required action).

Timepoint [9]

Over a 12-month period

Secondary outcome [10]

Confidence and competence: COPD self-efficacy (COPD Self-Efficacy Scale) and mastery domain of the CRQ. The COPD Self-Efficacy scale measures patient confidence regarding their ability to avoid breathing difficulty while participating in certain activities. The mastery domain of the CRQ measures the feeling of control one has over the disease and its effects.

Timepoint [10]

At the end of the 12-month period

Secondary outcome [11]

Cost data: intervention, health care interactions, travel, costs of usual care. ).

Australia: Incremental costs of all Australian patients will be estimated by applying Australian Refined Diagnosis Related Groups (AR-DRG) cost weights, Medicare Benefits Schedule (MBS) and PBS schedule prices and charges for staff time, consumable and overheads current at time of analysis.

Netherlands: Data regarding health care resource use (e.g. out-patient visits, hospitalisations and GP visits) will be retrospectively collected for all patients using the hospital and GP databases. Medication details for all patients will be retrospectively collected from the pharmacists. Resource use will be multiplied by unit prices. Medication costs will be based on market prices.

Timepoint [11]

Over a 12-month period

Secondary outcome [12]

Adverse events (e.g. Deaths). An external Data and Safety Monitoring Board will be asked to assess adverse events
each 6 months.

Timepoint [12]

6, 12, 18, and 24 months after the start of the trial.

Secondary outcome [13]

Satisfaction and confidence of health care providers (case-managers, nurse practitioners, physicians, and GPs) regarding self-treatment will be evaluated using semi-structured one on one interviews. Patients satisfaction and confidence will be evaluated using focus groups.

Timepoint [13]

After 12 months

Eligibility

Key inclusion criteria

1) a clinical diagnosis of COPD according to the GOLD criteria; 2) >= 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris); heart failure (defined according to the ESC guidelines; diabetes (stable type 1 or 2); or active symptoms of depression and/or anxiety (using cut-off scores from the Hospital Anxiety and Depression Scale (HADS); 3) >= 3 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or >= 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or Modified MRC (mMRC) score of 3 or 4; 4) >= 40 years of age; 5) stable at the time of inclusion (at least 6 weeks post-hospitalisation or post-rehabilitation); 6) FEV1 < 80% of the predicted value and FEV1/FVC<0.70; 7) able to understand and read the English or Dutch language; 8) written informed consent from the subject prior to participation.

Minimum age

40 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) terminal cancer or other serious disease with low survival rate; 2) End stage COPD or Chronic Heart Failure (expected survival <12 months) or any other condition which, according to expert clinical judgment of the Chief Investigator, is likely to limit 12-month survival; 3) other serious lung disease (e.g. alpha1-antitrypsin deficiency; interstitial lung diseases); 4) patients with active psychotic symptoms or suicidal ideation; 5) patients with cognitive impairment (Mini-Mental State Exam < 24); 6) patients who are currently enrolled in other clinical trials; 7) currently enrolled in other clinical trials or intensive case-management programs.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

300 patients (Australia: n=150; the Netherlands: n=150) will be recruited from the outpatient departments of respiratory medicine of the three public hospitals of the Southern Area, Adelaide Health Service in Australia (Flinders Medical Centre, Repatriation General Hospital, and Noarlunga Hospital, and one large hospital in Enschede, the Netherlands (Medisch Spectrum Twente). Patients will be allocated to the intervention or control group using minimisation programs managed by a third party.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Patients will be allocated to either the intervention or control group stratified for hospital site and balanced for potential confounders (smoking status, modified Medical Research Council (mMRC) dyspnoea score, and diagnostic group of comorbidities) using computerised minimisation programs managed by a third party.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/05/2012

Actual

1/06/2012

Date of last participant enrolment

Anticipated

Actual

1/06/2015

Date of last data collection

Anticipated

Actual

30/06/2016

Sample size

Target

300

Accrual to date

Final

201

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5041

Recruitment postcode(s) [2]

5042

Recruitment postcode(s) [3]

5168

Recruitment outside Australia

Country [1]

Netherlands

State/province [1]

Overijssel

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Lung Foundation Fellowship

Address [1]

44 Brookes Street
Bowen Hills QLD 4006
Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Netherlands Lung Foundation

Address [2]

Stationsplein 127
3818 LE Amersfoort
The Netherlands

Country [2]

Netherlands

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Stichting Astmabestrijding

Address [3]

Meibergdreef 15
1105 AZ Amsterdam

Country [3]

Netherlands

Funding source category [4]

Commercial sector/Industry

Name [4]

GlaxoSmithKline

Address [4]

Huis ter Heideweg 62
3705 LZ Zeist

Country [4]

Netherlands

Primary sponsor type

Hospital

Name

Repatriation General Hospital

Address

Daws Road
Daw Park SA 5041

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Medisch Spectrum Twente

Address [1]

Postbus 50 000
7500 KA Enschede

Country [1]

Netherlands

Secondary sponsor category [2]

Hospital

Name [2]

Flinders Medical Centre

Address [2]

Flinders Dr
Bedford Park SA 5042

Country [2]

Australia

Other collaborator category [1]

Hospital

Name [1]

Canisius-Wilhelmina Ziekenhuis Nijmegen

Address [1]

Weg door Jonkerbos 100
6532 SZ Nijmegen

Country [1]

Netherlands

Other collaborator category [2]

Hospital

Name [2]

Royal Adelaide Hospial

Address [2]

Port Rd
Adelaide SA 5000

Country [2]

Australia

Other collaborator category [3]

Hospital

Name [3]

Port Noarlunga Hospital

Address [3]

Alexander Kelly Drive
Noarlunga Centre SA 5168

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

the Flinders Southern Adelaide Clinical Human Research Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
The Flats G5, Rooms 3 and 4
Flinders Drive, Bedford Park
SA 5042
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/02/2012

Approval date [1]

02/05/2012

Ethics approval number [1]

37.12

Ethics committee name [2]

Medisch Ethische Toetsingscommissie Twente

Ethics committee address [2]

Medisch Spectrum Twente
t.a.v. Medisch Ethische Toetsingscommissie
Postbus 50 000
7500 KA Enschede

Ethics committee country [2]

Netherlands

Date submitted for ethics approval [2]

31/01/2012

Approval date [2]

03/04/2012

Ethics approval number [2]

P12-13, NL39516.044.12

Summary

Brief summary

COPD is a leading cause of death in Australia and its prevalence is increasing globally. The majority of disease burden and costs in COPD are due to treatment of exacerbations, with hospitalisations being the major component. Almost all comorbidities exist more frequently in COPD patients compared to matched elderly populations. One third of COPD patients admitted to hospital have at least four coded comorbidities, and these add to the length of hospital stay. In selected populations of COPD patients, training in the use of COPD action plans reduces COPD exacerbation severity, emergency department visits, hospitalisations and health costs and improves health status. However, overlap in symptoms of COPD and comorbidities complicate the use of COPD action plans in the large group of patients with comorbidities. For example, in a COPD patient with comorbid cardiovascular disease, worsening of his dyspnoea can relate to either disease. Use of only a COPD action plan could lead to incorrect actions and/or delay of proper treatment. We have developed self-treatment training with ongoing nurse support for complex COPD patients. Feedback to patients from nurses is vital to optimize use of action plans. We will enrol 300 COPD patients (150 in each of Australia and the Netherlands) with at least one of the following comorbidity: ischaemic heart disease, heart failure, diabetes, or anxiety/depression. All patients will complete daily symptom diaries for 12 months. Control patients will receive usual care and training in diary completion. Intervention patients will be trained in the use of individualized action plans. We hypothesize that this novel self-treatment strategy will reduce exacerbation severity, hospitalisation stay and costs, and improve quality of life.

Trial website

Trial related presentations / publications

Related presentations:

Invited presentations
1. Tanja Effing. New definition of self-management. Oral presentation. In: Workshop: Incorporating Telemedicine into the Integrated Care of the COPD Patient. European Respiratory Society (ERS) international congress, Milan, Italy, September 2017.
2. Tanja Effing. Self-management in COPD patients. Oral presentation. In: Postgraduate Course: Self-management in chronic respiratory diseases. ERS 2017, Milan, Italy, September 2017.
3. Anke Lenferink, Job van der Palen. Self-management in COPD. Oral presentation. In: Nederlandse Vereniging van Longfunctieanalisten (NVLA) Thorax Academy, Breukelen, the Netherlands, October 2016.
4.. Anke Lenferink, Job van der Palen, Tanja Effing. The future of COPD self-management care. Oral presentation. In: Dr. G.J. van Hoytema Stichting, Almelo, the Netherlands, June 2015.
5. Tanja Effing. Collaborative and non-collaborative self-management. Oral presentation and workshop. In: European Respiratory Society Pulmonary Rehabilitation Course. Horn, the Netherlands, October 2014.
6. Job van der Palen and Tanja Effing. Changing behaviour of COPD patients: using action plans and physical activity programs. Sunrise seminar. In: American Thoracic Society conference, San Diego, the United States of America, May 2014.
7. Tanja Effing. Individualised care in COPD: Self-management in COPD – pros. Oral presentation. In: Thoracic Society of Australia and New Zealand Annual Scientific Meeting, Adelaide, April 2014.
8. Anke Lenferink. Successful COPD self-management. Oral presentation & Workshop. In: V&VNVS congress, Arnhem, the Netherlands, October 2013.

International conference proceedings
1. Anke Lenferink, Job van der Palen, Paul van der Valk, Paul Cafarella, Anneke van Veen, Steve Quinn, Karin Groothuis-Oudshoorn, Morton Burt, Mary Young, Peter Frith, Tanja Effing. Effects of self-management action plans for COPD patients with comorbidities on health status and self-efficacy. Poster presentation. In: European Respiratory Society (ERS) 2017, Milan, September 2017..
2. Anke Lenferink, Job van der Palen, Paul van der Valk, Paul Cafarella, Anneke van Veen, Steve Quinn, Karin Groothuis-Oudshoorn, Morton Burt, Mary Young, Peter Frith, Tanja Effing. Self-management action plans for COPD patients with comorbidities reduce exacerbation duration and respiratory-related hospitalizations – the COPE-III study. Oral presentation. In: American Thoracic Society (ATS) International Conference 2017, Washington DC, United States of America, May 2017. Awarded an American Thoracic Society (ATS) International Trainee Scholarship Award 2017.
3. Anke Lenferink, Marjolein Brusse-Keizer, Paul van der Valk, Peter Frith, Marlies Zwerink, Evelyn Monninkhof, Job van der Palen, Tanja Effing. Self-management interventions including COPD exacerbation action plans improve hospitalisation rate and health-related quality of life – a Cochrane review. Oral presentation. In: Thoracic Society of Australia and New Zealand (TSANZ) 2017, Canberra, Australia, March 2017. Awarded a Lung Foundation Australia / Cochrane Airways Australia Scholarship 2016.
4. Anke Lenferink, Marjolein Brusse-Keizer, Paul van der Valk, Peter Frith, Marlies Zwerink, Evelyn Monninkhof, Job van der Palen, Tanja Effing. Self-management interventions that include COPD exacerbation action plans improve health-related quality of life – a Cochrane review. Poster presentation. In: European Respiratory Society (ERS) 2016, London, United Kingdom, September 2016.
5. Anke Lenferink, Job van der Palen, Peter Frith, Paul van der Valk, Tanja Effing. Differences in patient characteristics and associations with comorbid load in Dutch and Australian patients. Poster presentation. In: European Respiratory Society (ERS) 2016, London, United Kingdom, September 2016.
6. Anke Lenferink, Job van der Palen, Xin Wang, Paul van der Valk, Tanja Effing. Predictors for adherence to action plans for self-treatment of COPD exacerbations”. Poster presentation. In: Thoracic Society of Australia and New Zealand (TSANZ) 2016, Perth, Australia, April 2016.
7. Anke Lenferink, Muirne Paap, Peter Harvey, Malcolm Battersby, Peter Frith, Paul van der Valk, Wendy van Beurden, Job van der Palen, Tanja Effing. Validation of the 12-item Partners in Health scale to measure patient self-management behaviour and knowledge in Dutch patients with COPD. Poster presentation. In: European Respiratory Society (ERS) 2015 – Amsterdam, the Netherlands, September 2015.
8. Anke Lenferink, Job van der Palen, Peter Frith, Paul van der Valk, Tanja Effing. Associations between comorbid load and patient characteristics in COPD patients with comorbidities: preliminary results. Oral presentation. In: Thoracic Society of Australia and New Zealand (TSANZ) 2015, Gold Coast, Queensland, Australia, April 2015.
9. Anke Lenferink, Job van der Palen, Peter Frith, Paul van der Valk, Tanja Effing. Associations between comorbid load and baseline characteristics in COPD patients with comorbidities: preliminary results. Poster presentation. In: European Respiratory Society (ERS) 2014 – Munich, Germany, September 2014.

Dutch conference proceedings:
1. Anke Lenferink, Job van der Palen, Paul van der Valk, Anneke van Veen, Karin Groothuis-Oudshoorn, Peter Frith, Tanja Effing. The effects of individualised action plans for the selftreatment of exacerbations in patients with COPD and comorbidities. Oral presentation. In: Longdagen 2017, Ermelo, the Netherlands, April 2017. Awarded a Lung Foundation Netherlands Audience Award 2017.
2. Anke Lenferink, Job van der Palen, Peter Frith, Paul van der Valk, Tanja Effing. Associations between comorbid load and baseline characteristics in COPD patients with comorbidities: preliminary results. Poster presentation. In: Ketenzorgdag, Utrecht, the Netherlands, January 2015.
3. Anke Lenferink, Job van der Palen, Peter Frith, Paul van der Valk, Tanja Effing. Associations between comorbid load and baseline characteristics in COPD patients with comorbidities: preliminary results. Poster presentation. In: Longdagen, Utrecht, the Netherlands, October 2014.
4. Anke Lenferink, Peter Frith, Paul van der Valk, Julie Buckman, Ruth Sladek, Paul Cafarella, Job van der Palen, Tanja Effing. An innovative self-management approach in COPD patients with comorbidities. Poster presentation. In: Ketenzorgdag, Utrecht, the Netherlands, October 2013.
5. Anke Lenferink, Peter Frith, Paul van der Valk, Julie Buckman, Ruth Sladek, Paul Cafarella, Job van der Palen, Tanja Effing. An innovative self-management approach in COPD patients with comorbidities. Poster presentation. In: Longdagen, Utrecht, the Netherlands, April 2013.

Related publications:
1. Lenferink A, Brusse-Keizer M, van der Valk PDLPM, Frith PA, Zwerink M, Monninkhof EM, van der Palen J, Effing TW. Self-management interventions including action plans for exacerbations versus usual care in patients with chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2017, Issue 8. Art. No.: CD011682.  
2. Lenferink A, Effing T, Harvey P, Battersby M, Frith P, van Beurden W, van der Palen J, Paap MC. Construct Validity of the Dutch Version of the 12-Item Partners in Health Scale: Measuring Patient Self-Management Behaviour and Knowledge in Patients with Chronic Obstructive Pulmonary Disease. PLoS One. 2016;11(8):e0161595.
3. Effing TW, Vercoulen JH, Bourbeau J, Trappenburg J, Lenferink A, Cafarella P, Coultas D, Meek P, van der Valk P, Bischoff EW, Bucknall C, Dewan NA, Early F, Fan V, Frith P, Janssen DJ, Mitchell K, Morgan M, Nici L, Patel I, Walters H, Rice KL, Singh S, Zuwallack R, Benzo R, Goldstein R, Partridge MR, van der Palen J. Definition of a COPD self-management intervention: International Expert Group consensus. Eur Respir J. 2016;48(1):46-54.
4. Effing TW, Lenferink A, Buckman J, Spicer D, Cafarella PA, Burt MG, Bassett KL, van Ommeren C, Anesbury S, van der Valk PD, Frith PA, van der Palen J. Development of a self-treatment approach for patients with COPD and comorbidities: an ongoing learning process. J Thorac Dis 2014;6(11):1597-1605. 
5.. Lenferink A, Frith P, van der Valk P, Buckman J, Sladek R, Cafarella P, van der Palen J,  Effing T. A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol. Contemp Clin Trials. 2013;36(1):81-9.

Submitted article:
Lenferink A, van der Palen J, van der Valk PDLPM, Cafarella P, van Veen A, Quinn S, Groothuis-Oudshoorn CGM, Burt MG, Young M, Frith PA, Effing TW. Exacerbation action plans for patients with COPD and comorbidities.

Public notes

Contacts

Principal investigator

Name

Dr Anke Lenferink (Netherlands), Tanja Effing (Australia)

Address

Anke Lenferink
Medisch Spectrum Twente
Koningsplein 1
7500 KA Enschede
Netherlands

Tanja Effing
Flinders Medical Centre
Flinders Drive
Bedford Park 5042 SA
Australia

Country

Netherlands

Phone

+31 53 489 6311

Fax

[email protected]

Contact person for public queries

Name

Tanja Effing

Address

Repatriation General Hospital
Daws Road
Daw Park SA 5041

Country

Australia

Phone

+61 8 8275 1189

Fax

+61 8 8275 1195

[email protected]

Contact person for scientific queries

Name

Tanja Effing

Address

Repatriation General Hospital
Daws Road
Daw Park SA 5041

Country

Australia

Phone

+61 8 8275 1189

Fax

+61 8 8275 1195

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

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Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: The COPE-III study protocol	2013	https://doi.org/10.1016/j.cct.2013.06.003
Embase	Construct validity of the Dutch version of the 12-item partners in health scale: Measuring patient self-management behaviour and knowledge in patients with chronic obstructive pulmonary disease.	2016	https://dx.doi.org/10.1371/journal.pone.0161595
Embase	Predictors of patient adherence to COPD self-management exacerbation action plans.	2021	https://dx.doi.org/10.1016/j.pec.2020.06.015

N.B. These documents automatically identified may not have been verified by the study sponsor.

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