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Trial registered on ANZCTR


Registration number
ACTRN12620001330932
Ethics application status
Approved
Date submitted
12/09/2020
Date registered
9/12/2020
Date last updated
9/12/2020
Date data sharing statement initially provided
9/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathless Clinic - working together to defeat breathlessness in chronic obstructive pulmonary disease (COPD)
Scientific title
Breathless Clinic - working together to defeat breathlessness in chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 300314 0
Nil known
Universal Trial Number (UTN)
U1111-1246-9645
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 315918 0
chronic obstructive pulmonary disease (COPD) 315919 0
Condition category
Condition code
Respiratory 314190 314190 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the implementation of the Breathless Clinic (BC), a nine weeks’ programme to manage refractory breathlessness. The intervention duration is planned for a period of 12 months, so as to minimise the impact of seasonal variation on our results. The follow up duration comprises 12 months (from initial enrolment in clinic).
Following assessment, review and optimisation of pharmacotherapies, non-pharmacologic treatment interventions will commence and further investigations and referrals will be undertaken as required. The most crucial aspect of BC, is to provide coaching for dyspnoea self-management and daily coping strategies for survival in the domestic setting or community; for example, breathing techniques, posture, fans and self-talk (offered through senior specialist respiratory nursing colleagues) and the strategies provided to improve efficiency and therefore manage breathlessness during day-to-day activities, tailored for individual patients in the home setting, by our physiotherapy and occupational therapy clinicians. These aspects may allow for greater independence and participation in community activities. "Home visits" and standard clinic visits will usually occur face to face but may also utilise telephone or videoconference depending on the patient circumstances and preferences.

Non-pharmacologic breathlessness interventions (examples):
Beliefs
• Validation of breathlessness
• Clarifying mistaken beliefs (breathlessness is not always due low oxygen levels, breathlessness itself is not dangerous)
• Motivational interviewing

Strategies
• Hand-held, battery-operated fan
• “Breathing around the rectangle”, “flickering the candle” (single breath)
• Other breathing techniques (breathing pattern) – paced or diaphragmatic breathing, “blow as you go”
• Positions to relieve breathlessness

Training
• Walking program (supported by use of a pedometer)

Aids/efficiency
• four-wheel walker/ shower chair
• Energy conservation (save energy on what you must do, so that you have some spare to participate in activities that you enjoy).
• Home modifications
• Referral to dietitian if underweight/ malnourished

Education and Self-management
• Written breathlessness action plans* (3 Fs - lean Forward, Focus on breath out, Fan; 3Ps - Pause, Purse lips, Position)
• Written COPD exacerbation action plan** (guide of what to do in an exacerbation)
• Breathlessness DVD*** – reinforces key interventions to relieve breathlessness
• Relaxation CD***

Miscellaneous
• Sputum clearance techniques
• Carer support
• Management of incontinence

BC schedule
The clinic itself comprises eight to nine healthcare interactions over nine weeks, with most interactions occurring within the patient’s home;

Week 1 (patient’s home) – Initial assessment, Respiratory Nurse, research assistant
Week 2 (outpatient clinic) – Formulate Management Plan, Multidisciplinary Team
Week 3 (patient’s home) – Physiotherapist
Week 4 (patient’s home) – Occupational Therapist (as required)
Week 5 (patient’s home) – Respiratory Nurse
Week 6 (patient’s home) – Physiotherapist
Week 7 (patient’s home) – Respiratory Nurse
Week 8 (patient’s home) – Final assessments, research assistant
Week 9 (outpatient clinic) – Closure and follow up arrangements, Multidisciplinary Team

Clinical items to be reviewed/assessed at BC visits 1 and 2
1) Heart rate, blood pressure, respiratory rate and oxygen saturation
2) Electrocardiogram (ECG)
3) Height and weight
4) Most recent measures:
a) spirometry or complex lung function within previous 12 months
b) inflammation (white cell count and differential, C-reactive protein) within previous 12 months
c) cardiac biomarkers (high sensitivity Troponin T, NT-proB-type Natriuretic Peptide) within previous 12 months
d) microbiology (any positive gram stains, cultures and available antibiotic sensitivities, any positive respiratory viral screens within previous 12 months)
e) 6 minute walk test (6MWT), if available, within 12 months
5) Comorbidities and current medications
6) Mini Nutritional Assessment (MNA)
7) Eating Assessment Tool (EAT-10)
8) Exacerbation history
9) Healthcare visit data
10) COPD action plan

Clinic team: Specialist Respiratory Physician, Specialist Respiratory Nurse, Senior Physiotherapist (with experience running pulmonary rehabilitation program), Senior Occupational Therapist.
The clinic team will deliver the intervention as per the clinic program above. The team may also include general practitioner, senior registrars in Cardiology and Respiratory Medicine

All clinic interactions will ideally involve a single participant and their partner/carer (if relevant). The sessions will last 30 - 120 minutes.

Since BC is part of the clinic services of our hospital, each clinic interaction will be recorded within each subject's electronic medical record (EMR). Compliance for some individualised BC components will be assessed (for example step counts measured by pedometer for patients receiving exercise recommendations to achieve a goal daily step count). However, for the most part, the assessment of adherence to clinic recommendations will be subjective (by patient report) and captured during the post-clinic interviews collecting qualitative data, along with the patients' perception of which clinic interventions were most and least helpful for managing their breathlessness.

* Written breathlessness action plans, resources originally developed by Cambridge Breathlessness Intervention Service and distributed via their education seminars, then adapted for use in Westmead Hospital's breathlessness clinic service (used with permission)
** COPD action plan, readily available free resource from Lung Foundation Australia, routinely used in clinical practice
*** Breathlessness DVD, developed for breathlessness clinics at Westmead Hospital and used with permission.
**** Relaxation CD, developed for breathlessness clinics at Westmead Hospital and used with permission.

Note: Westmead Hospital's Breathlessness Clinic service has provided collaboration and mentorship in developing/designing the clinic used in this intervention, which has been adapted to the Campbelltown Hospital setting. Associated Investigator TS is also a lead clinician within the Westmead Hospital breathlessness service.




Intervention code [1] 316610 0
Treatment: Other
Intervention code [2] 318905 0
Lifestyle
Intervention code [3] 318906 0
Behaviour
Comparator / control treatment
The control is "standard care" which may involve pulmonary rehabilitation, general practice review, outpatient specialist clinic review, community nursing involvement.
Participants will act as their own controls, with breathlessness impact data being compared with baseline and health outcome data (from the previous 12 months) being compared with the 12 months from commencement of protocol.
Benchmarking with similar or theoretically comparable populations will also be applied, where appropriate, for healthcare outcomes:
1. comparison of unplanned admission rates and unplanned hospital bed days within the year of the study with the corresponding figures for a population comprising all patients hospitalised within Campbelltown Hospital with diagnostic related group (DRG) code "COPD" during the 12 months prior to BC commencement (study participants excluded).
2. comparison of unplanned admission rates and unplanned hospital bed days within the year of the study with the corresponding figures for population comprising all patients presenting to Campbelltown Emergency Department with the triage category "SOB respiratory" (Shortness of breath, respiratory) during the 12 months prior to BC commencement
Study participants will be excluded from populations used for benchmarking.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322598 0
Mastery of breathlessness as measured by Chronic Respiratory disease Respiratory Questionnaire (CRQ) - mastery subscale
Timepoint [1] 322598 0
Baseline, 9 weeks post-commencement of intervention (primary timepoint), 26 and 52 weeks post-commencement of intervention
Secondary outcome [1] 379013 0
Breathlessness impact:
Total CRQ score and (other) subscale scores
Timepoint [1] 379013 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention
Secondary outcome [2] 379014 0
Breathlessness impact:
Breathlessness intensity and unpleasantness numerical rating scale (NRS)
Timepoint [2] 379014 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention
Secondary outcome [3] 379015 0
Breathlessness impact::
COPD Assessment Test (CAT) score
Timepoint [3] 379015 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention




Secondary outcome [4] 388202 0
Breathlessness impact::
Hospital Anxiety and Depression (HAD) Score
Timepoint [4] 388202 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [5] 388203 0
Breathlessness impact::
EQ-5D-5L
Timepoint [5] 388203 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [6] 388204 0
Breathlessness impact::
Average number of steps per day (as measured by pedometer) over the past 7 days.
Timepoint [6] 388204 0
Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [7] 388205 0
Number of unplanned healthcare presentations in 12 months since BC enrolment (overall number)
Data will be sourced from EMR and corroborated/supplemented by patient report and general practice records. Analysis will compare with the 12 months prior to BC enrolment.


Timepoint [7] 388205 0
52 weeks post-commencement of intervention
Secondary outcome [8] 388206 0
Healthcare outcomes:
Number of unplanned healthcare presentations in 12 months since BC enrolment (related to breathlessness)
Data will be sourced from EMR and corroborated/supplemented by patient report and general practice records. Analysis will compare with the 12 months prior to BC enrolment.
Timepoint [8] 388206 0
52 weeks post-commencement of intervention
Secondary outcome [9] 388207 0
Healthcare outcomes:
Number of unplanned hospital admissions in 12 months since BC enrolment (overall number)
Data will be sourced from EMR and corroborated/supplemented by patient report and general practice records. Analysis will compare with the 12 months prior to BC enrolment. Benchmarking: comparison of unplanned admission rate for the population comprising all patients admitted to Campbelltown Hospital with diagnostic related group (DRG) code "COPD" during the 12 months of study follow up (study participants excluded).
Timepoint [9] 388207 0
52 weeks post-commencement of intervention
Secondary outcome [10] 388208 0
Healthcare outcomes:
Number of unplanned hospital admissions in 12 months since BC enrolment (related to breathlessness)
Data will be sourced from EMR and corroborated/supplemented by patient report and general practice records. Analysis will compare with the 12 months prior to BC enrolment.
Benchmarking:
1. comparison with unplanned admission rate for the population comprising all patients hospitalised at Campbelltown Hospital with diagnostic related group (DRG) code "COPD" during the 12 months of study follow up (study participants excluded).
2. comparison with unplanned admission rates for the population comprising all patients presenting to Campbelltown Hospital Emergency Department in the triage category "SOB (shorthness of breath) - respiratory" during the 12 months of study follow up (study participants excluded).
Timepoint [10] 388208 0
52 weeks post-commencement of intervention
Secondary outcome [11] 388209 0
Healthcare outcomes:
SWSLHD Hospital bed days in the 12 months after BC enrolment.
Data will be sourced from EMR.
Benchmarking:
1. comparison with SWSLHD hospital bed days for the population comprising all patients hospitalised at Campbelltown Hospital with diagnostic related group (DRG) code "COPD" during the 12 months of study follow up (study participants excluded).
2. comparison with hospital bed days for the population comprising all patients presenting to Campbelltown Hospital Emergency Department in the triage category "SOB (shortness of breath) - respiratory" during the 12 months of study follow up (study participants excluded).
Timepoint [11] 388209 0
52 weeks post-commencement of intervention
Secondary outcome [12] 388210 0
Healthcare outcomes:
Occasions of activation of COPD action plan in the 12 months after BC enrolment
Data collected (patient report) at each follow up visit/ phone call for the duration of the study
Timepoint [12] 388210 0
52 weeks post-commencement of intervention
Secondary outcome [13] 388211 0
Healthcare outcomes:
Occasions of prescription of antibiotics and/or corticosteroid for the treatment of a respiratory exacerbation in the 12 months after BC enrolment
Data collected (patient report) at each follow up visit/ phone call for the duration of the study and corroborated/supplemented by general practice records
Timepoint [13] 388211 0
52 weeks post-commencement of intervention
Secondary outcome [14] 388212 0
Qualitative analysis
Perspectives from patients and carers, based on their experiences of BC, will be explored via interview and analysed using qualitative thematic analysis to identify key concepts and themes. Patients and carers (if applicable) will be interviewed together. We will seek feedback from the consumers involved in the BC intervention, using qualitative research to develop a deeper understanding of their experience, which can be used to inform interpretation of trial outcomes and further refinement and adaptation of the intervention for other settings.
Interview will generally be face to face, although there is provision to undertake the interviews via telephone or videoconference medium, depending on the participants' circumstances and preferences.
Timepoint [14] 388212 0
Consumer feedback will be sought at conclusion of the BC intervention and take the form of a standardised semi-structured interview (10-18 weeks).

Eligibility
Key inclusion criteria
a) Clinical and spirometric diagnosis of COPD with FEV1<80% predicted; FEV1/FVC ratio <70%
b) Severe breathlessness: modified Medical Research Council (mMRC) scale >1 (on mMRC 0-4 scale; that is, “On level ground, I walk slower than people of the same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level”)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Bed-bound or moribund
b) Dementia or cognitive impairment sufficient to impair participation in education strategies
c) Current active diagnosis of cancer, substance abuse (other than nicotine dependence), other uncontrolled medical or psychiatric disorder.
d) A history of recent moderate to severe exacerbation of COPD, requiring hospitalization within the preceding 4 weeks.
e) Insufficient knowledge of the English language to comprehend interventions and/or complete assessment questionnaires.
f) Currently enrolled in pulmonary rehabilitation (but may participate if still eligible upon program completion). Still eligible if involved in long term maintenance program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants receive the same intervention throughout the study.
For the primary outcome and most secondary outcomes, the participant results post intervention will be compared to those obtained at baseline (subjects will act as their own controls).
The study's qualitative component will explore perspectives from patients and carers, based on their experiences of BC, to identify key concepts and themes and to inform future adaptations of the clinic model.
Some secondary healthcare outcomes will be benchmarked (see previous sections) against populations in which outcomes might be expected to be similar, such as "patients admitted with DRG code COPD" and patients triaged in the Emergency Department as "SOB - respiratory". However, benchmarking is not being undertaken for the primary outcome and so such analyses should be regarded as "exploratory".
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Breathless Clinic (BC) will be evaluated by means of a pre- and post-intervention study, with subjects acting as their own controls, before and after the clinic intervention duration of nine weeks. Twelve months’ follow up data will provide further information about the sustainability of outcomes.
Recruitment target estimation is constrained by limited precedent data, We have estimated sample size for this study on limited data from one small study of a population similar to our own, and other study populations comprising patients with refractory dyspnoea but quite different from our own. Considering these data, we have set our BC recruitment goal at 92 subjects, in anticipation of 30% discontinuation or dropout.
The subject group will be characterised by application of descriptive statistics to clinic baseline data collected prior to the first hospital visit.
The clinical effectiveness outcome measures (breathlessness impact) will be repeated at clinic completion and 12 months to compare with the baseline assessments, assessing for any effect of the BC intervention and whether that effect is sustained. Healthcare outcome data for BC patients will be compared with that for the previous 12 months and benchmarked, where appropriate. For continuous data, statistical comparison will be undertaken using T tests, provided that the data is normally distributed and subject to normal transformation prior to analysis if they are not. Comparisons will be made between baseline and 9 weeks (BC completion); baseline and 12 months, 9 weeks (BC completion) and 12 months. Categorical data will be compared using Chi squared or Fisher’s exact test, as appropriate. Subjects' compliance/fidelity with individual components of the BC intervention will be correlated with clinical and healthcare outcomes, in an attempt to determine which components are the most important contributors to outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
Date of last participant enrolment
Anticipated
29/11/2021
Actual
Date of last data collection
Anticipated
28/11/2022
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15671 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 29080 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 304741 0
Commercial sector/Industry
Name [1] 304741 0
GlaxoSmithKline Research & Development Limited
Country [1] 304741 0
United Kingdom
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
Administration Building, Eastern Campus, Liverpool Hospital, Locked Bag 7279, Liverpool BC 1871
Country
Australia
Secondary sponsor category [1] 305106 0
None
Name [1] 305106 0
Address [1] 305106 0
Country [1] 305106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305160 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305160 0
Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 305160 0
Australia
Date submitted for ethics approval [1] 305160 0
07/07/2020
Approval date [1] 305160 0
07/09/2020
Ethics approval number [1] 305160 0

Summary
Brief summary
Breathlessness is a distressing and incapacitating symptom, responsible for a high proportion of healthcare separations and costs with far-reaching consequences in terms of affected individuals’ quality of life, independence, community interactions and workforce participation. Patients suffering refractory breathlessness and their caregivers feel that awareness of the symptom burden amongst healthcare providers and provision to address this burden within healthcare services is lacking.
Breathless Clinic (BC), is a 9 week, predominantly home-based, multidisciplinary “clinic” for COPD patients with refractory dyspnoea. Through BC an individualised treatment plan is developed, comprising a variety of non-pharmacologic interventions to help patients manage their breathlessness in the community.
Hypothesis: Participation in BC will result in an improvement in patients' ability to cope with breathlessness, as evidenced by improvements in measures of breathlessness impact (breathlessness severity and intensity, symptoms burden, depression and anxiety, health status status and health-related quality of life). Participation in BC will also reduce healthcare outcomes such as healthcare usage and respiratory exacerbations (flares of COPD).
Trial website
Trial related presentations / publications
Public notes
Pulmonary rehabilitation (PR) as described in the Pulmonary Rehabilitation Tool Kit (Lung Foundation Australia) is arguably the most well-recognised non-pharmacologic treatment strategy in COPD. Patients are strongly encouraged to complete PR prior to enrolling in BC, although attendance/completion is not required for eligibility.

Breathlessness impact:
Permission is also being sought to use the Dalhousie Dyspnoea and Perceived Exertion Scale from the owner/developers (Pianosi PT, Zhang Z, Hernandez P, Huebner M. Measuring dyspnea and perceived exertion in healthy adults and with respiratory disease: new pictorial scales. Sports medicine-open. 2016 Dec;2(1):17.)

Contacts
Principal investigator
Name 99442 0
A/Prof Belinda Cochrane
Address 99442 0
Department of Medicine, Campbelltown Hospital
PO Box 149
Campbelltown
NSW 2560
Country 99442 0
Australia
Phone 99442 0
+61 2 46344001
Fax 99442 0
+61 2 46344011
Email 99442 0
[email protected]
Contact person for public queries
Name 99443 0
Belinda Cochrane
Address 99443 0
Department of Medicine, Campbelltown Hospital
PO Box 149
Campbelltown
NSW 2560
Country 99443 0
Australia
Phone 99443 0
+61 2 46344001
Fax 99443 0
+61 2 46344011
Email 99443 0
[email protected]
Contact person for scientific queries
Name 99444 0
Belinda Cochrane
Address 99444 0
Department of Medicine, Campbelltown Hospital
PO Box 149
Campbelltown
NSW 2560
Country 99444 0
Australia
Phone 99444 0
+61 2 46344001
Fax 99444 0
+61 2 46344011
Email 99444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be made available due to the potential for increased risk of subjects being individually identified in a single centre study recruiting from the local catchment community


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.