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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]

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

Condition category

Condition code

Respiratory

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Aboriginal Health Worker knowledge of COPD management using the BE WELL Health Provider Impact Questionnaire (designed specifically for the study)

Timepoint [1]

Before and immediately after the BE WELL Workshop and again at 6 months and 12 months follow-up.

Primary outcome [2]

Functional exercise capacity using the validated six-minute walk test (6MWT) in participants in the pulmonary rehabilitation program.

Timepoint [2]

Before and at completion of the 8-week pulmonary rehabilitation program

Primary outcome [3]

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]

Before and at completion of the 8-week pulmonary rehabilitation program

Secondary outcome [1]

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]

12 months before commencing the pulmonary rehabilitation program and 12 months after completion of the pulmonary rehabilitation program

Secondary outcome [2]

Factors affecting implementation of BE WELL using focus groups of Aboriginal Health Workers.

Timepoint [2]

Focus groups will be held at project inception, and 3 and 12 months after the BE WELL workshop

Secondary outcome [3]

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]

At initial consultation before the BE WELL workshop and at 3 and 12 months after the workshop.

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,NT,QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
Postal address:
GPO Box 1421
Canberra ACT 2601
Physical Address:
16 Marcus Clarke St
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Aboriginal Health and Medical Research Council

Ethics committee address [1]

PO Box 1565
Strawberry Hills
NSW 2012

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/03/2017

Approval date [1]

12/05/2017

Ethics approval number [1]

1261/17

Summary

Brief summary

Chronic obstructive pulmonary disease (COPD) affects approximately 20% of Indigenous Australian adults and an even greater proportion in remote regions. The prevalence of COPD is 2.5 times higher, death rate from COPD is three times higher and hospitalisation rates are five times higher in Aboriginal and Torres Strait Islander peoples than in non-Indigenous Australians. Best-practice care of COPD includes accurate diagnosis, smoking cessation, optimising medication and pulmonary rehabilitation to improve symptoms, activity levels and well-being. There is Level 1 evidence that pulmonary rehabilitation for people with COPD improves quality of life and reduces disability, reduces hospital admissions and length of stay, and is cost-effective. However, the implementation of this effective intervention into clinical practice in Indigenous communities is virtually non-existent, furthering the inequity of access to best-practice management of chronic lung disease. 

The research project will evaluate the implementation of an innovative program, the Breathe Easy Walk Easy Lungs for Life (BE WELL) program, in four distinct Aboriginal communities - metropolitan, regional, rural, remote- using the Knowledge to Action Framework. The BE WELL program aims to build the capacity of Aboriginal and Torres Strait Islander health workers to deliver best-practice management of COPD, Specifically, the project will evaluate the ability of the program to increase Aboriginal health workers’ knowledge and skills in managing COPD; improve exercise capacity and health-related quality of life of Indigenous people with COPD; and reduce hospital admissions and length of hospital stay for exacerbations of COPD. The resources for this program have been developed but the BE WELL program has not been implemented in Indigenous communities. We hypothesise that the BE WELL program will improve Aboriginal health worker knowledge and skills in the management of COPD and, for Indigenous people with COPD, BE WELL will improve exercise capacity and quality of life, and reduce hospital admissions and length of hospital stay. Knowledge gained from this project will be valuable for policy makers and health services in informing the future response to chronic lung disease management in Indigenous communities.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jennifer Alison

Address

Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141

Country

Australia

Phone

+61 414300416

Fax

+61 2 9351 9601

jennifer.alison@sydney.edu.au

Contact person for public queries

Name

Jennifer Alison

Address

Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141

Country

Australia

Phone

+61 414300416

Fax

+61 2 9351 9601

jennifer.alison@sydney.edu.au

Contact person for scientific queries

Name

Jennifer Alison

Address

Faculty of Health Sciences
The University of Sydney
75 East street
Lidcombe NSW 2141

Country

Australia

Phone

+61 414300416

Fax

+61 2 9351 9601

jennifer.alison@sydney.edu.au

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

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
New Record*	Study results article	Yes	https://doi.org/10.1186/s12889-023-15508-y	14. Meharg DP, Dennis SM, McNab J, Gwynne KG, Jenk... [More Details]	2023_Meharg et al_A mixed methods study of Aboriginal health workers _published.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Implementing evidence into practice to improve chronic lung disease management in Indigenous Australians: the breathe easy, walk easy, lungs for life (BE WELL) project (protocol).	2022	https://dx.doi.org/10.1186/s12890-022-02033-8

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

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