Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001337369
Ethics application status
Approved
Date submitted
2/09/2017
Date registered
20/09/2017
Date last updated
20/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing chronic lung disease in Aboriginal communities: the Breathe Easy Walk Easy-Lungs for Life (BE WELL) project
Scientific title
Implementing evidence into practice to improve chronic lung disease management in Indigenous Australians: the Breathe Easy, Walk Easy - Lungs for Life (BE WELL) project
Secondary ID [1] 292801 0
National Health and Medical Research Council (NHMRC), Global Alliance for Chronic Diseases (GACD) initiative, Application Number: 1116081
Universal Trial Number (UTN)
Trial acronym
The BE WELL project
Breathe Easy Walk Easy Lungs for Life (BE WELL) project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 304614 0
Condition category
Condition code
Respiratory 303934 303934 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two levels of intervention:
1. A 2 day workshop to upskill Aboriginal Health Workers in the assessment of people with chronic obstructive pulmonary disease (COPD) and the provision of a pulmonary rehabilitation program. The workshop will be provided by a physiotherapist experienced in the assessment of patients with COPD and in the provision of pulmonary rehabilitation. The workshop attendees will be Aboriginal Health Workers, who will either be undertaking or have completed a Certificate IV in Allied Health Assistance with a major in Fitness Training. It is anticipated that there will only be a small group of attendees at each workshop within an Aboriginal Medical Service. The workshop will have theory and practice components and will include: assessment of lung function (spirometry); functional exercise capacity using the six-minute walk test (6MWT); quality of life using the Indigenous version of the St George's Respiratory Questionnaire (SGRQ-I) and the COPD Assessment Test (CAT); exercise prescription; education about lung disease; how to deliver a pulmonary rehabilitation program; and patient reassessment at program completion. The workshop will incorporate the 8 ways of Aboriginal learning to facilitate engagement of Aboriginal Health Workers.

2. Aboriginal or Torres Strait Islander people with COPD will be invited to attend a supervised pulmonary rehabilitation program, twice a week for eight weeks at the Aboriginal Medical Services. Exercise sessions will be approximately 1 hour. The exercise training prescription for each participant will be individualised and based on their functional exercise capacity measured on entry to the pulmonary rehabilitation program with the aim of participants exercising at a level that achieves a breathlessness or rate of perceived exertion score of 3 to 4 (‘moderate’ to ‘somewhat severe’) on the Borg 0-10 scale. The exercise training program will consist of aerobic, strength and balance exercises. Walking training and/or dance will be used for aerobic exercise. Body weight and/or resistance bands will be used for lower limb strengthening. Hand weights and/or resistance bands will be used for upper limb strengthening. Specific balance training will include exercise such as changes in body position, standing and walking on uneven surfaces, single leg standing.
The exercise and education components of the program will be developed in consultation with the Aboriginal communities at each participating Aboriginal Medical Services to ensure that they are culturally appropriate. The exercise training will be supervised by an accredited exercise physiologist or physiotherapist and an Aboriginal health worker with an Allied Health Assistant Certificate IV and a major in Fitness Training.
Intervention code [1] 299045 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303275 0
Aboriginal Health Worker knowledge of COPD management using the BE WELL Health Provider Impact Questionnaire (designed specifically for the study)
Timepoint [1] 303275 0
Before and immediately after the BE WELL Workshop and again at 6 months and 12 months follow-up.
Primary outcome [2] 303276 0
Functional exercise capacity using the validated six-minute walk test (6MWT) in participants in the pulmonary rehabilitation program.
Timepoint [2] 303276 0
Before and at completion of the 8-week pulmonary rehabilitation program
Primary outcome [3] 303277 0
Health-related quality of life of participants in the pulmonary rehabilitation program using the St George's Respiratory Questionnaire validated in Indigenous populations.
Timepoint [3] 303277 0
Before and at completion of the 8-week pulmonary rehabilitation program
Secondary outcome [1] 338505 0
Number of hospitalisations for an exacerbation of COPD.
Hospitalisations will be measured by review of medical records if participants consent. If consent is not given for medical record review, participants will be asked to recall number of hospitalisations.
Timepoint [1] 338505 0
12 months before commencing the pulmonary rehabilitation program and 12 months after completion of the pulmonary rehabilitation program
Secondary outcome [2] 338506 0
Factors affecting implementation of BE WELL using focus groups of Aboriginal Health Workers.
Timepoint [2] 338506 0
Focus groups will be held at project inception, and 3 and 12 months after the BE WELL workshop
Secondary outcome [3] 338507 0
Services provided by Aboriginal Medical Services to assess and manage COPD using the BE WELL Service Delivery Inventory developed specifically for the project.
Timepoint [3] 338507 0
At initial consultation before the BE WELL workshop and at 3 and 12 months after the workshop.
Secondary outcome [4] 338604 0
Length of hospital stay for an exacerbation of COPD.
Length of hospital stay will be measured by review of medical records if participants consent. If consent is not given for medical record review, participants will be asked to recall length of hospital stay
Timepoint [4] 338604 0
12 months before commencing the pulmonary rehabilitation program and 12 months after completion of the pulmonary rehabilitation program

Eligibility
Key inclusion criteria
Aboriginal Health Workers will be eligible for inclusion if they are employed in a participating Aboriginal Medical Service and are enrolled in or have completed the Certificate 4 in Allied Health Assistant.

Patients will be eligible if they have a diagnosis of COPD. confirmed by spirometry with a forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio (FEV1/FVC) of < 0.7
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be co-morbidities such as severe cardiovascular, neurological or musculoskeletal conditions that are likely to adversely affect performance during assessments or exercise training.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample sizes have been calculated for the quantitative measurements. For evaluating changes in health worker knowledge of COPD management, the scores from the objective knowledge test in BE WELL Health Provider Impact Questionnaire will be used. The sample size required, based on our pilot data demonstrating change in knowledge score of 7 marks (SD 4.5), eight Aboriginal health worker participants would be required, with a power of 80%, alpha 0.05, allowing for a 20% dropout. For the patient outcomes, based on our pilot study, to detect a change in 6-minute walk test of 48 metres (SD 70) with a power of 80% and alpha 0.05, 40 patients will be required, allowing for a 20% dropout. For quality of life, to detect a -4 point improvement in SGRQ-I (which is the minimal important difference with SD 6 points, 42 patients will be required, allowing for a 20% dropout, with power 80% and alpha 0.05. For hospitalisations, a Cochrane review demonstrated a 24% difference in hospital readmissions between those receiving pulmonary rehabilitation compared to those who did not. We have conservatively assumed a 20% reduction in hospital admissions. Therefore 97 patients would be needed, power 80%, alpha 0.05, allowing for 15% drop-out. Based on the largest patient sample size required, 97 patients will be recruited,

Data will be collated and analysed using SPSS statistics package. Before and after BE WELL workshop scores will be compared using paired-t-tests. Repeated measure ANOVA will be used to evaluate Aboriginal Health Worker knowledge retention over time. For categorical measures of self-rated knowledge, confidence and skills, change scores will be calculated and analysed using Wilcoxon’s signed ranks test.

Patient outcomes for exercise capacity and health-related quality of life will be compared before and after pulmonary rehabilitation using paired t-tests. Hospital admissions and length of hospital stay for respiratory related care in the 12 months before and after pulmonary rehabilitation will be compared using paired-t tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2017
Actual
Date of last participant enrolment
Anticipated
3/04/2020
Actual
Date of last data collection
Anticipated
3/06/2021
Actual
Sample size
Target
97
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD

Funding & Sponsors
Funding source category [1] 297432 0
Government body
Name [1] 297432 0
National Health and Medical Research Council
Country [1] 297432 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of sydney
City Road,
Camperdown/Darlington
NSW 2006
Country
Australia
Secondary sponsor category [1] 296428 0
None
Name [1] 296428 0
Address [1] 296428 0
Country [1] 296428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298541 0
Aboriginal Health and Medical Research Council
Ethics committee address [1] 298541 0
Ethics committee country [1] 298541 0
Australia
Date submitted for ethics approval [1] 298541 0
17/03/2017
Approval date [1] 298541 0
12/05/2017
Ethics approval number [1] 298541 0
1261/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77398 0
Prof Jennifer Alison
Address 77398 0
Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141
Country 77398 0
Australia
Phone 77398 0
+61 414300416
Fax 77398 0
+61 2 9351 9601
Email 77398 0
[email protected]
Contact person for public queries
Name 77399 0
Jennifer Alison
Address 77399 0
Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141
Country 77399 0
Australia
Phone 77399 0
+61 414300416
Fax 77399 0
+61 2 9351 9601
Email 77399 0
[email protected]
Contact person for scientific queries
Name 77400 0
Jennifer Alison
Address 77400 0
Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141
Country 77400 0
Australia
Phone 77400 0
+61 414300416
Fax 77400 0
+61 2 9351 9601
Email 77400 0
[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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementing evidence into practice to improve chronic lung disease management in Indigenous Australians: the breathe easy, walk easy, lungs for life (BE WELL) project (protocol).2022https://dx.doi.org/10.1186/s12890-022-02033-8
N.B. These documents automatically identified may not have been verified by the study sponsor.