Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000933257p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2018
Date registered
1/06/2018
Date last updated
20/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost effectiveness of extending the community pulmonary rehabilitation phase 3 program
Scientific title
Cost effectiveness of extending the community pulmonary rehabilitation phase 3 program
Secondary ID [1] 295024 0
Nil
Universal Trial Number (UTN)
Trial acronym
ComEx3
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 308040 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307093 307093 0 0
Physiotherapy
Respiratory 307124 307124 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention arm will continue attending their weekly Phase 3 maintenance pulmonary rehabilitation at their current venue for another 6 months. The pulmonary rehabilitation is delivered by a senior physiotherapist from Community Physiotherapy Services at one of seven community centres in metropolitan Western Australia (i.e. Beechboro, Craigie, Hamersley, Jolimont, Joondalup, Morley and Swan). Each 75-minute pulmonary rehabilitation group session will comprise a 20-minute walking program, flexibility and stretching exercises (i.e. calf stretches, chest stretch and chest turns), and a six-station exercise circuit within the enclosed community centre. The circuit comprises unsupported upper limb exercises (i.e. arm raises, forward punches, elbow curls and upright row) and lower limb exercises (i.e. step-ups, sit to stand, wall squats, mini-squats, heel raises). The modalities of exercise used in the exercise circuit are individualised to each participant based on their responses to the dyspnoea domain of the chronic respiratory disease questionnaire (CRQ).

In addition participants will be instructed to walk at least 20 minutes and perform the prescribed exercises on 4 or 5 days a week at home. The prescribed exercises are those performed during the pulmonary rehabilitation class - i.e. stretching exercises, leg exercises and arm exercises. Participants will be provided with a diary to record their compliance to the home exercise program. The diaries will be completed on a weekly basis and collected every 3 months via reply-paid post. A research associate will send out monthly reminders by short message service (SMS) reminding participants to complete their exercise diary.

The intervention arm is called "Community Program" for the purpose of this trial.
Intervention code [1] 301353 0
Rehabilitation
Comparator / control treatment
Participants randomised to the control arm will not attend any further Phase 3 maintenance pulmonary rehabilitation sessions. They will be instructed to walk at least 20 minutes and perform the prescribed exercises on 4 or 5 days a week at home. The prescribed exercises are those they had performed during their earlier pulmonary rehabilitation classes - i.e. stretching exercises, leg exercises and arm exercises. Participants will be provided with a diary to record their compliance to the home exercise program. The diaries will be completed on a weekly basis and collected every 3 months via reply-paid post. A research associate will send out monthly reminders by SMS reminding participants to complete their exercise diary.

The control arm is called "Home Program" for the purpose of this trial.
Control group
Placebo

Outcomes
Primary outcome [1] 306054 0
Health-related quality of life using the disease specific Chronic Respiratory Disease Questionnaire (CRQ).
Timepoint [1] 306054 0
This outcome measure will be assessed at 0, 6 and 12 months (primary endpoint) post-intervention commencement.
Primary outcome [2] 306088 0
Health-related quality of life using the generic SF-36 health survey.
Timepoint [2] 306088 0
This outcome measure will be assessed at 0, 6 and 12 months (primary endpoint) post-intervention commencement.
Primary outcome [3] 306089 0
Impact of COPD on participant's health using COPD Assessment Test (CAT).
Timepoint [3] 306089 0
This outcome measure will be assessed at 0, 6 and 12 months (primary endpoint) post-intervention commencement.
Secondary outcome [1] 347442 0
We will assess participants' functional exercise capacity using the 6-minute walk test. This will be conducted at their pulmonary rehabilitation venue by a senior physiotherapist blinded to the treatment allocation.
Timepoint [1] 347442 0
This outcome measure will be assessed at 0, 6 and 12 months post-intervention commencement.
Secondary outcome [2] 347443 0
We will assess the number of non-hospitalised exacerbations. A non-hospitalised exacerbation is defined as a worsening of the lung condition that required the participant to use antibiotics, steroids/prednisolone, increase their inhaler use as instructed by their doctor, visit their GP and/or visit their specialist but without a corresponding hospital admission. This will be determined from the participants' symptom diary which is provided together with the exercise diary.
Timepoint [2] 347443 0
This will be assessed in the 0 to 12-month period from intervention commencement.
Secondary outcome [3] 347444 0
We will assess respiratory-related hospitalisations in terms of number of admissions and total bed days. This will be determined from the participants' symptom diary which is provided together with the exercise diary. If the participant is admitted to hospital, we will collect the following information in the symptom diary - admission and discharge dates, hospital, ward, discharge diagnosis/reason for admission.

We will also access electronic hospital admission records at Western Australian hospitals to collect information on admission and discharge dates, hospital, ward, discharge diagnosis/reason for admission.
Timepoint [3] 347444 0
This will be assessed in the 0 to 12-month period from intervention commencement.
Secondary outcome [4] 347445 0
We will assess all-cause hospitalisations in terms of number of admissions and total bed days. This will be determined from the participants' symptom diary which is provided together with the exercise diary. If the participant is admitted to hospital, we will collect the following information in the symptom diary - admission and discharge dates, hospital, ward, discharge diagnosis/reason for admission.

We will also access electronic hospital admission records at Western Australian hospitals to collect information on admission and discharge dates, hospital, ward, discharge diagnosis/reason for admission.
Timepoint [4] 347445 0
This will be assessed in the 0 to 12-month period from intervention commencement.
Secondary outcome [5] 347446 0
We will explore the potential cost savings and cost effectiveness to the Western Australian health system.

Ascertainment of hospital admissions have been described in Secondary Outcomes 4. Costs for all-cause hospital based health care resource use will be obtained from the Finance and Performance unit of the Western Australian Department of Health. The total cost of hospital admissions will be calculated using average daily cost for the condition multiplied by the length of stay. Costs for providing the Phase 3 pulmonary rehabilitation program will be obtained from Community Physiotherapy Services.

The total health care resource use (cost of providing extended Phase 3 pulmonary rehabilitation program + cost of hospital-based health care resource) will be determined on an intention-to-treat basis. All costs will be indexed to 2018 costs. . Sensitivity analyses will be performed on all variables where the assumptions used can vary.

A cost-effectiveness analysis will compare differences in costs and quality adjusted life years (QALYs) between the two treatment arms in the 12-month period from intervention commencemen. SF-36 response scores will be converted into utility values using an algorithm for the Australian population, with QALYs calculated from utility values. The perspective adopted for the evaluation will be the Western Australian health system. Incremental cost-effectiveness ratios will be calculated as the difference in the cost of the intervention and control arms divided by the difference in QALYs (QALY difference is between 0 and 12 months post-intervention commencement).
Timepoint [5] 347446 0
0 to 12 month period from intervention commencement
Secondary outcome [6] 347525 0
Participant's views of the interventional and control arms will be determined from focus groups. The focus groups will involve 10 participants from each of the intervention and control arms and will be conducted by a trained interviewer.
Timepoint [6] 347525 0
Focus groups will be conducted in the 12 to 18 month period post-intervention commencement.

Eligibility
Key inclusion criteria
All participants with stable COPD (forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio<70% and FEV1<80% predicted) who completed >70% of the Community Physiotherapy Services 10-week Phase 3 maintenance pulmonary rehabilitation program. Stable is defined as not having respiratory flare-ups requiring antibiotics, prednisolone or respiratory-related hospitalisation in the past 6 weeks.

Participants will be recruited from the seven Community Physiotherapy Services pulmonary rehabilitation venues in metropolitan Western Australia - Beechboro, Craigie, Hamersley, Jolimont, Joondalup, Morley and Swan
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded due to illness, co-morbidities and disability; or insufficient English to provide written informed consent or able to complete the assessment questionnaires. Furthermore, participants who are considered medically not indicated for pulmonary rehabilitation such as those who consistently walked more than 1800m in 20 minutes and SpO2>90% during their Phase 3 class will be excluded. Consistently is defined as 3 or more occasions.

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)
Contacting the holder of the allocation schedule who is based at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random allocation list will be generated using a statistical software package. A statistician will perform randomisation in block sizes of 2, 4 or 6, in a 1:1 allocation ratio, and stratified by pulmonary rehabilitation venue. The randomised allocation list will be uploaded onto a REDCap database
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcomes will be analysed for superiority. Superiority analyses will be two-sided, and considered statistically significant at the 5% level. All analyses will be conducted on both an intention-to-treat and per-protocol basis.

Outcomes will be analysed initially using a t-test or Mann Whitney non-parametric test to compare the two treatment arms. Subsequent supporting analyses using mixed effects models including fixed effects of time, treatment group and time by treatment group interaction as appropriate and random effects of individual. An appropriate correlation structure for the errors will be incorporated

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 299604 0
Government body
Name [1] 299604 0
Western Australian Department of Health, Research Translation Projects 2018-19.
Country [1] 299604 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway, Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 298925 0
None
Name [1] 298925 0
Address [1] 298925 0
Country [1] 298925 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300505 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 300505 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA 6150
Ethics committee country [1] 300505 0
Australia
Date submitted for ethics approval [1] 300505 0
28/05/2018
Approval date [1] 300505 0
19/06/2018
Ethics approval number [1] 300505 0
Ethics committee name [2] 300507 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 300507 0
35 Stirling Highway,
Crawley, WA 6009
Ethics committee country [2] 300507 0
Australia
Date submitted for ethics approval [2] 300507 0
02/07/2018
Approval date [2] 300507 0
Ethics approval number [2] 300507 0
Ethics committee name [3] 300524 0
Western Australian Department of Health
Ethics committee address [3] 300524 0
189 Royal Street,
East Perth, WA 6004
Ethics committee country [3] 300524 0
Australia
Date submitted for ethics approval [3] 300524 0
28/05/2018
Approval date [3] 300524 0
13/06/2018
Ethics approval number [3] 300524 0

Summary
Brief summary
Pulmonary rehabilitation (PR) is an evidence-based intervention recommended for people with chronic obstructive pulmonary disease (COPD), the second leading cause of avoidable hospitalisation in Australia. PR improves quality of life and reduces health care utilisation. However, any benefit from completing Phase 2 (“initial”) PR diminishes in the months following. Currently, participants are invited to continue attending a weekly Phase 3 (“maintenance”) program for 10 weeks. With lack of robust evidence supporting the benefits of Phase 3 PR, program funding is constantly threatened. The 2017 Australia and New Zealand Pulmonary Rehabilitation Clinical Practice Guidelines calls for further research to clarify the benefits of Phase 3 PR. Our primary aim is to compare the health-related quality of life (HRQoL) in participants receiving the extended Phase 3 PR against those not receiving the extended program. We hypothesise that in the 6 months following completion of the extended Phase 3 PR program, participants who completed the extended program will have a better HRQoL than the control group. We will randomise participants who have completed a Phase 3 PR program to either a further 6 months of the maintenance program plus unsupervised home exercise (community program) or 6 months of unsupervised home exercise (home program).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83878 0
Dr Derrick Lopez
Address 83878 0
School of Population and Global Health,
The University of Western Australia
35 Stirling Highway,
Crawley, WA 6009
Country 83878 0
Australia
Phone 83878 0
+61 8 6488 1276
Fax 83878 0
Email 83878 0
derrick.lopez@uwa.edu.au
Contact person for public queries
Name 83879 0
Dr Derrick Lopez
Address 83879 0
School of Population and Global Health,
The University of Western Australia
35 Stirling Highway,
Crawley, WA 6009
Country 83879 0
Australia
Phone 83879 0
+61 8 6488 1276
Fax 83879 0
Email 83879 0
derrick.lopez@uwa.edu.au
Contact person for scientific queries
Name 83880 0
Ms Nola Cecins
Address 83880 0
Sir Charles Gairdner Hospital
Hospital Avenue,
Nedlands, WA 6009
Country 83880 0
Australia
Phone 83880 0
+61 8 6457 4408
Fax 83880 0
Email 83880 0
nola.cecins@health.wa.gov.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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMaintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: Protocol for a randomised controlled trial (ComEx3 Study).2020https://dx.doi.org/10.1136/bmjresp-2019-000548
N.B. These documents automatically identified may not have been verified by the study sponsor.