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Trial registered on ANZCTR


Trial ID
ACTRN12617000499381
Ethics application status
Approved
Date submitted
27/03/2017
Date registered
6/04/2017
Date last updated
1/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non drug interventions to reduce breathlessness in patients with Chronic Obstructive Pulmonary Disease (Emphysema)
Scientific title
Randomised controlled trial of a non-pharmacological integrated care intervention to reduce breathlessness in patients with severe or very severe chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 291325 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 302304 0
Breathlessness 302305 0
Condition category
Condition code
Respiratory 301889 301889 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After the clinic assessment, subjects will receive a range of interventions to address their breathlessness. These are derived from evidence based interventions and will include breathing techniques, positions to aid breathing, a hand held fan (supported by a Breathlessness DVD- made by Westmead Hospital based on existing literature supervised by Clinical nurse consultant in respiratory medicine with more than 20 years experience) relaxation and breathing strategies supported by a custom made CD (made by Westmead Hospital specifically for this clinic with input from a psychologist with greater than 10 years clinical experience), basic advice about pacing activities, a walking program and nutritional advice. Patient handouts have been developed to reinforce the advice given in clinic. Interventions will be individualised for individuals. This will occur as part of the multi-disciplinary team meeting which involves personnel form the disciplines of medicine, nursing, physiotherapy, occupational therapy, dietetics and clinical psychology. Each individuals treatment will be dictated by their clinical needs. Adherence with suggested interventions will be assessed at weekly multidisciplinary meetings and recorded in trial database. Duration of the intervention will be for 8 weeks.
Breathing techniques are essentially pursed lip breathing and ‘breathing around the rectangle’ which reduces dynamic hyperinflation. Patients are advised to practise these techniques when they are breathless until the breathlessness episode resolves. Positions essentially involve lean forward postures with arms supported to aid recover from breathless episodes. Relaxation involves assessing patients psychological reaction to breathless episodes and suggesting individualised advice depending on patients’ needs. Basic advice about pacing includes the importance of planning activities of daily living and utilising strategies which allowed the activity to be broken into a number of steps and undertaking each step as breathlessness and energy levels allow. A walking program involves assessing patients physical activity using a pedometer and suggesting goal step counts for patients who are able to increase their step counts. The walking program will be customised to each patients based on their step count during the first week. Nutritional advice involves assessing the patients weight and food intake. Patients with low BMI or who are found to be malnourished or at risk of malnutrition using the Mini Nutritional assessment will receive further input from a dietitian with 15years experience. The delivery of the intervention will be different for patients and will depend on their needs and previous experiences with breathlessness. All patients will receive some advice in the initial clinic appointment. This clinic is delivered by a clinical nurse consultant with more the 20 years’ experience and a respiratory physician with training in palliative care with almost 20 years post graduate experience. The clinic visit lasts approximately one hour. This initial clinic advice will be supported by a range of handouts developed for this clinic. Following initial assessment, patients will receive further advice on the above techniques depending on their need. This advice will be delivered by face to face assessments supported by phone calls. Clinicians involved in delivering this advice include a physiotherapist, occupational therapist and clinical nurse consultant.
Intervention code [1] 297353 0
Treatment: Other
Intervention code [2] 297582 0
Lifestyle
Comparator / control treatment
control group is assigned to a wait list and will wait 8 weeks until commencing the intervention. Assignment is random.
Standard care patients will receive basic information regarding COPD, assessment and correction of their inhaler technique and supply of an action plan. This will be the comparator to the treatment
Control group
Active

Outcomes
Primary outcome [1] 301316 0
Mastery of breathlessness in patients with COPD as measured by CRQ mastery of breathlessness subscale.
Timepoint [1] 301316 0
8 weeks
Secondary outcome [1] 332288 0
breathlessness as measured by a numerical rating scale of breathlessness intensity,
Timepoint [1] 332288 0
8 weeks
Secondary outcome [2] 333361 0
breathlessness unpleasantness as measured by a numerical rating scale of breathlessness unpleasantness.
Timepoint [2] 333361 0
8 weeks
Secondary outcome [3] 333362 0
quality of life as measured by other chronic respiratory questionnaire subscales specifically, dyspnoea, emotional functioning and fatigue subscales
Timepoint [3] 333362 0
8 weeks
Secondary outcome [4] 333363 0
anxiety and depression as measured by hospital anxiety and depression scale. This is a single tool that reports two subscales within the one questionnaire.
Timepoint [4] 333363 0
8 weeks
Secondary outcome [5] 333364 0
health status related to COPD as measured by COPD assessment test score
Timepoint [5] 333364 0
8 weeks
Secondary outcome [6] 333365 0
physical activity as measured by steps per day using a pedometer over 7 days. The average over this time period will be used
Timepoint [6] 333365 0
8 weeks
Secondary outcome [7] 333366 0
total number of hospitalisations
Timepoint [7] 333366 0
12 months from the beginning of the study
Secondary outcome [8] 333367 0
Emergency Department presentations related to breathlessness
Timepoint [8] 333367 0
12 months from the beginning of the study
Secondary outcome [9] 333368 0
Survival at 6 months and 12 months post completion of the program.
Timepoint [9] 333368 0
6 months and 12 months post completion of the program
Secondary outcome [10] 333447 0
Hospitalisation number related to breathlessness
Timepoint [10] 333447 0
12 months post completion of the program

Eligibility
Key inclusion criteria
a) Moderate to very severe COPD by GOLD criteria (FEV1 less than 60% predicted; FEV1/FVC ratio less than 70%)
b) Severe breathlessness: mMRC greater than or equal to 2 (on mMRC 0-4 scale; ie “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”)
c) Subject is willing and able to be an active participant in their care
d) Either completed pulmonary rehabilitation within 1 year or unwilling to attempt pulmonary rehabilitation due to perceived breathlessness (NB randomisation will be stratified for pulmonary rehab completion as these may be clinically different groups and we wish to ensure equal numbers from these categories in each group)
e) Informed consent given
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Bed bound
b) Diagnosis of dementia or cognitive impairment
c) Subject unwilling or unable to actively participate in trying new interventions to address breathlessness
d) No usual medical practitioner (either specialist or general practitioner (GP)) involved in the patient’s care
e) Subject unable to comply with study procedures in the opinion of the investigator or the subject’s usual medical team
f) Subjects with a current active diagnosis of cancer, primary respiratory disease other than COPD, substance abuse, other uncontrolled medical disorder.
g) Subjects with a moderate to severe exacerbation of COPD requiring hospitalisation within the last 4 weeks.
h) Subjects with a primary diagnosis of congestive cardiac failure
i) Inability to understand sufficient English to complete study procedures or instruments

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Randomised controlled, parallel group (with wait list control), single blind clinical trial (short term intensive clinical intervention compared with standard care).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on our pilot data, forty-seven patients per group would detect a mean difference in change from baseline of 1.1 units (SD 1.6 units) in mastery of breathlessness as measured by the CRQ (MCID 0.5 units), with a at 0.05 and power 80%. This allows for 25% attrition.
Primary analyses will use the intention to treat principle. If the 8 week information is unavailable then it will be imputed with the most recent data. The primary analysis for all normally distributed, continuous outcomes will use an analysis of covariance adjusting for the patient’s baseline value. For non-normally distributed outcomes a similar approach will be used, using the appropriate model (e.g. Poisson or negative binomial). We will also compare the proportion of subjects achieving the MCID for each outcome using a chi-squared test. The time to death will be analysed using a proportional hazards regression.
Given the integrative nature of qualitative analysis, a sample size of 15 patients will likely be adequate. Sampling for the focus groups will include all health professionals involved in delivering the service.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7715 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 15637 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 295788 0
Commercial sector/Industry
Name [1] 295788 0
HCF Research Foundation
Address [1] 295788 0
Level 8 , 403 George Street, Sydney, 2000
Country [1] 295788 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 294902 0
None
Name [1] 294902 0
NONE
Address [1] 294902 0
None
Country [1] 294902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297085 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297085 0
Research office, Research & Education building, Westmead hospital
Cnr Hawkesbury and Darcy Rd Westmead NSW 2145
Ethics committee country [1] 297085 0
Australia
Date submitted for ethics approval [1] 297085 0
13/04/2016
Approval date [1] 297085 0
30/06/2016
Ethics approval number [1] 297085 0
Au RED HREC16/WMEAD/131 (4670)

Summary
Brief summary
The aim of this project is examine non drug methods of relieving breathlessness. We will also examine the effects of the non drug interventions on anxiety, depression and quality of life in this patient population with severe chronic obstructive lung disease.
We will ask all patients attending the breathlessness clinic to participate. They will be randomly assigned to either start the interventions for breathlessness immediately or delayed start in 8 weeks. All patients will receive current standard of care.
They will be asked to complete questionnaires, wear a pedometer (step counter), and to undergo breathing and walking tests.
We hope that we can prove non drug management of breathlessness is possible in this patient population.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1605 1605 0 0

Contacts
Principal investigator
Name 72926 0
Prof John Wheatley
Address 72926 0
Department of Respiratory & Sleep Medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 72926 0
Australia
Phone 72926 0
+61298456797
Fax 72926 0
+61298457286
Email 72926 0
john.wheatley@sydney.edu.au
Contact person for public queries
Name 72927 0
Ms Tracy Smith
Address 72927 0
Department of Respiratory & Sleep Medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 72927 0
Australia
Phone 72927 0
+61288905626
Fax 72927 0
+61288907286
Email 72927 0
Tracy.Smith2@health.nsw.gov.au
Contact person for scientific queries
Name 72928 0
Ms Tracy Smith
Address 72928 0
Department of Respiratory & Sleep Medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 72928 0
Australia
Phone 72928 0
+61288905626
Fax 72928 0
+61288907286
Email 72928 0
Tracy.Smith2@health.nsw.gov.au