Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001253190
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
11/09/2019
Date last updated
14/02/2023
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the mobile pulmonary rehabilitation (m-PR) platform on exercise capacity and health status in people with chronic lung disease
Scientific title
Evaluation of the mobile pulmonary rehabilitation (m-PR) platform on exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD): A randomised controlled trial
Secondary ID [1] 299079 0
None
Universal Trial Number (UTN)
Trial acronym
m-PR trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 314108 0
Condition category
Condition code
Respiratory 312484 312484 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the mobile pulmonary rehabilitation (m-PR) program which will consist of an eight week pulmonary rehabilitation intervention conducted in the home of the participant supported by the use of a mobile application.

Following the initial assessment of the participant, the m-PR app will be uploaded onto the participants own device (Smartphone). An education session on use of the m-PR app will be provided to the participant together with a hard copy instruction manual. A COPD Action Plan will be discussed with the participant as part of m-PR. The participants will then be asked to commence the eight week m-PR program at home and will be contacted once per week either via phone or videoconferencing facilities as part of m-PR. The m-PR platform will contain the following specific components:

1. Daily symptom diary: Daily symptoms (breathlessness, cough, sputum colour, sputum volume, wheeze) will be recorded on the m-PR platform by participants. Symptoms will be scored and graphed over time for discussion between participants and physiotherapist.
2. Exercise Prescription: Following the exercise assessment at the PR centre, m-PR will contain an individually prescribed (by the physiotherapist) exercise program (8 weeks x 3 times per week) supported by exercise videos. The exercise sessions will include aerobic exercise, using a modality accessible to the participant, which is usually walking (or use of stationary cycle or treadmill if available) and strength training using functional activities and equipment that are readily accessible in the home environment (e.g. sit to stand, squats, stepping, arm exercises). Participants will be instructed to indicate when each exercise is completed with the data (date, time, duration, sets and repetitions of each exercise) recorded on the m-PR platform. Progression of exercise training will be considered on a weekly basis by the physiotherapist and will be individualized to each participant but may involve an increase in duration or intensity of aerobic training and/or an increase in sets or repetitions for strength training. This will be updated in the exercise training section of the platform. Motivating text messages from a pool of standard messages will be sent as reminders to facilitate training compliance.
3. Educational videos: Personalised education sessions, consisting of videos, will be scheduled and automatically delivered to the m-PR platform each week based on topics that the physiotherapist has identified as relevant to that participant. These videos have been designed specifically for this study. Motivating text messages about the educational content can also be sent including reminders to watch the videos if necessary. Data on participant use of the educational videos (date, time, duration) will be recorded on the m-PR app.
4. Electronic COPD action plan: Entry of prescribed inhaled medicines will automatically populate the electronic Lung Foundation Australia COPD action plan on the m-PR platform. Participants will use m-PR to review the action plan and record their actions taken. Data on the use of the COPD action plan (i.e. if opened in m-PR by participants) will be recorded on m-PR.
5. Physical activity plan: The plan for physical activity prescribed by the physiotherapist will be uploaded to m-PR. Participants may use an activity monitor or the motion sensors built into the smartphone to automatically monitor physical activity (step number, duration). Text messages will be sent to the mobile phone to encourage physical activity.
6. Inhaler technique videos: Instructional videos for inhaler technique from the Lung Foundation Australia website will be integrated in the m-PR platform for regular use. Data on the use of the inhaler technique videos (date, time, duration) will be recorded.
7. CAT questionnaire: participants will be asked to complete the CAT once a week via the m-PR app. The CAT scores will be used to track the participants well being during the m-PR program on a weekly basis.

The physiotherapist involved in managing the participants will access information through a "clinician portal". This is where the physiotherapists upload the required components of the program to be shown on the participant interface. Information on intervention adherence will also be available from the portal. The portal is a secure system, with all information kept fully confidential. Data will only be accessible by the physiotherapist and research team.
Intervention code [1] 315346 0
Rehabilitation
Intervention code [2] 315347 0
Behaviour
Intervention code [3] 315348 0
Treatment: Other
Comparator / control treatment
The control group will participate in a standard, face to face pulmonary rehabilitation program. This program will be twice a week for eight weeks according to current best practice guidelines. Each group-based session at a rehabilitation centre will consist of supervised, individually-prescribed exercise training and self-management education. At least 30 minutes of aerobic exercise training is performed each session, under the supervision of a physiotherapist, plus strength exercises using functional activities such as stair climbing and sit-to-stand practice, as well as free weights for the upper limbs. Participants will also be encouraged to exercise at home on at least one occasion each week. This exercise training program will be as individually-prescribed as the exercise training in the m-PR program although there will be one more session of face to face supervision for this group compared to the once weekly interaction between therapist and participant as part of the m-PR group. Self-management training will be approximately 45 minutes in duration and include structured (lecture-based) and unstructured disease management education and goal setting, covering standard topics including management of exacerbations and use of COPD action plan, understanding medications, nutrition support, and ongoing participation in exercise. Various members of the pulmonary rehabilitation multi-disciplinary team (eg physiotherapist, nurse, dietician, psychologist) are involved in the delivery of the education content.
Control group
Active

Outcomes
Primary outcome [1] 321129 0
exercise capacity: change in six minute walk distance from a six minute walk test
Timepoint [1] 321129 0
change from baseline to eight weeks following the intervention
Primary outcome [2] 321130 0
health status: change in COPD Assessment Test (CAT) score
Timepoint [2] 321130 0
change from baseline to eight weeks following the intervention
Secondary outcome [1] 374063 0
Health related quality of life (HRQoL): change in the total score and symptoms/activity/impact scores from the St George’s Respiratory Questionnaire (SGRQ)
Timepoint [1] 374063 0
change from baseline to eight weeks following the intervention
Secondary outcome [2] 374064 0
Symptoms of Breathlessness: change in the modified Medical Research Council [mMRC] breathlessness scale
Timepoint [2] 374064 0
change from baseline to eight weeks following the intervention
Secondary outcome [3] 374065 0
Lower limb strength: change in the five sit-to-stand test (5STS) time
Timepoint [3] 374065 0
change from baseline to eight weeks following the intervention
Secondary outcome [4] 374067 0
Psychological status - change in the scores of the Hospital Anxiety and Depression scale
Timepoint [4] 374067 0
change from baseline to eight weeks following the intervention
Secondary outcome [5] 374068 0
Daily physical activity levels; change in steps using the activPAL monitor
Timepoint [5] 374068 0
change from baseline to eight weeks following the intervention
Secondary outcome [6] 374069 0
Hospital admissions; The number of hospitalisations for a COPD exacerbation and the length of stay for a COPD exacerbation
Timepoint [6] 374069 0
Hospital admission data from the 12 months before and 12 months after the intervention
Secondary outcome [7] 374071 0
Satisfaction with the m-PR or face to face program using a custom-design satisfaction survey
Timepoint [7] 374071 0
eight weeks following the intervention
Secondary outcome [8] 374073 0
Uptake of the interventions: This will be determined by tracking the number and proportion of eligible people with COPD across the sites who enrol in m-PR (i.e. number enrolled in either intervention divided by eligible COPD people who were invited to participate in the intervention).
Timepoint [8] 374073 0
at the end of the eight week interventions
Secondary outcome [9] 374074 0
Adverse Events: The number of any participant-reported major or minor adverse events associated with either intervention.
-Major or minor adverse events could be factors that result from completing an exercise training program. However, adverse events associated with pulmonary rehabilitation programs are rare.
-An example of a major adverse event could be a serious cardiovascular episode such as a myocardial infarct or a fall that results in serious injury.
-An example of a minor adverse event could be extreme breathlessness or extreme muscle fatigue or injury.
Timepoint [9] 374074 0
at the end of the eight week interventions
Secondary outcome [10] 374075 0
Usability of the m-PR platform: Participants in the m-PR group only will be able to rate their usability of the platform using the System Usability Scale (SUS)
Timepoint [10] 374075 0
at the end of the m-PR intervention by m-PR participants and physiotherapists
Secondary outcome [11] 374322 0
change in time spent in sedentary/light/moderate/vigorous activity using the activPAL monitor
Timepoint [11] 374322 0
change from baseline to eight weeks following the intervention
Secondary outcome [12] 374323 0
Enjoyment with the m-PR or face to face program using the Physical Activity Enjoyment Scale (PACES)
Timepoint [12] 374323 0
eight weeks following the intervention
Secondary outcome [13] 374324 0
Completion of the interventions: The number of people who complete final assessment following the interventions divided by the number of people who started the interventions
Timepoint [13] 374324 0
at the end of the eight week interventions
Secondary outcome [14] 374326 0
Rating of the m-PR platform will be measured by both participants and physiotherapists using the Mobile Application Rating Scale: User version (u-MARS) addressing engagement, functionality, aesthetics and information quality within the platform.
Timepoint [14] 374326 0
at the end of the m-PR intervention by m-PR participants and physiotherapists
Secondary outcome [15] 406291 0
Lower limb endurance: change in one minute sit-to-stand (1minSTS) time
Timepoint [15] 406291 0
change from baseline to eight weeks following the intervention
Secondary outcome [16] 406292 0
Use of non-hospital resources (GP, specialists, allied health) using a custom-designed survey.
Timepoint [16] 406292 0
Change from baseline to eight weeks following the intervention, six months and twelve months post end of intervention
Secondary outcome [17] 406293 0
Patient costs including travel costs, productivity costs and other patient costs associated with the rehabilitation programs using a custom-designed survey,
Timepoint [17] 406293 0
eight weeks following the intervention
Secondary outcome [18] 406294 0
Health related quality of life (HRQoL) and quality-adjusted life-years (QALY) gained from the disease-generic utility-based EuroQol five dimensions, five levels (EQ-5D-5L) questionnaire
Timepoint [18] 406294 0
Change from baseline to eight weeks following the intervention

Eligibility
Key inclusion criteria
People will be eligible for inclusion if they:
• are aged greater than or equal to 18 years and have a medical diagnosis of COPD (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of less than 0.7; FEV1 less than 80% predicted normal)
• are current or former smokers
• have access to, and regular use of, the internet via Smartphone
• are willing and able to take part in the m-PR program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they have:
• had an acute exacerbation of COPD in the last two weeks;
• have musculoskeletal, cardiovascular or neurological conditions that means they are not able to perform exercise assessments or complete exercise training which might include (but are not limited to) severe mobility issues due to arthritis or a stroke or unstable cardiac disease;
• participated in any supervised exercise training within the last 12 months;
• limited English language skills which might hinder their understanding of the m-PR platform;
• limitations to the use of mobile technology (not interested in using mobile technology; non-correctable vision, hearing, cognitive or dexterity impairment; psychological conditions impairing use of mobile technology).

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)
Participants will be randomised in a concealed (de-identified) manner using a central randomisation process by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation by minimisation into a 1:1 ratio to an intervention group (m-PR) or a control group, favouring the intervention group (m-PR). Randomisation will be stratified according to exercise capacity, regular use of technology, and study centre.
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 to determine the effectiveness of m-PR to face to face rehabilitation (i.e. 6MWD, health status, HRQoL, mMRC, lower limb endurance, lower limb strength, psychological status, daily physical activity levels, satisfaction) will be analyzed on an intention-to-treat basis and a per-protocol basis and a p-value of < 0.05 considered significant. Linear mixed models will be estimated for the clinical and health outcomes at the different time points and used to assess whether there are important differences in them between the m-PR and face to face rehabilitation groups. Data will be presented as the mean and 95% confidence interval for the difference between groups with equivalence limits determined for each outcome (e.g. for the primary outcome of 6MWD the equivalence limit will be set as -30 metres and for the CAT score the equivalence limit will be -2 points which are both based on the minimum clinically important differences for these outcomes).
The hospital utilisation outcome will be determined in the 12 months prior to the interventions and the 12 months after program completion with the between group difference in the change in hospitalisation determined using an independent t-test.
The program outcomes (ie uptake and completion) will be determined as absolute numbers and percentages of uptake and completion within each group with the frequency distribution compared across groups using a Chi-square test.

Due to this trial having an equivalent co-primary outcome, the starting point for the health economic analysis will be to examine whether the m-PR intervention is least costly for achieving the clinical/health outcomes specified or not. If it is demonstrated that m-PR and the face to face intervention outcomes are not equivalent, then a cost-utility analysis will be conducted with the main summary measure – i.e. the incremental cost effectiveness ratio (ICER) – corresponding to the economic cost per QALY obtained at the conclusion of the trial. The bootstrapping procedure will be applied to the original data to produce a total of 10,000 simulated samples. These data will be used to compute both the mean and standard deviations of these costs and outcomes, and the 95% confidence intervals for the ICERs considered. The incremental costs and outcomes will be assembled on the cost-effectiveness plane with willingness-to-pay lines imposed, enabling the acceptability of m-PR to be assessed from the perspective of the healthcare provider. Sensitivity analysis will be conducted and described. The final part of the analysis will consist of examining the predictors for several events occurring over time amongst participants in the different interventions (such as admissions to hospital, HRQoL and functionality) using longitudinal/time-to-event or duration analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
4/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303614 0
Government body
Name [1] 303614 0
Northern Sydney Local Health District
Country [1] 303614 0
Australia
Funding source category [2] 303615 0
University
Name [2] 303615 0
University of Sydney
Country [2] 303615 0
Australia
Funding source category [3] 303616 0
Government body
Name [3] 303616 0
CSIRO
Country [3] 303616 0
Australia
Funding source category [4] 303617 0
Charities/Societies/Foundations
Name [4] 303617 0
Better Breathing Foundation
Country [4] 303617 0
Australia
Funding source category [5] 303619 0
Charities/Societies/Foundations
Name [5] 303619 0
Lung Foundation Australia
Country [5] 303619 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
75 East St Lidcombe, NSW, 1825
Country
Australia
Secondary sponsor category [1] 303705 0
None
Name [1] 303705 0
Address [1] 303705 0
Country [1] 303705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304144 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 304144 0
NSLHD Research Office

Level 13, Kolling Building

Royal North Shore Hospital
Reserve Rd, St Leonards, NSW, 2065
Ethics committee country [1] 304144 0
Australia
Date submitted for ethics approval [1] 304144 0
08/04/2019
Approval date [1] 304144 0
10/05/2019
Ethics approval number [1] 304144 0
2019/ETH00368

Summary
Brief summary
The primary objective of this study is to determine, in people with COPD, if a mobile pulmonary rehabilitation (m-PR) program is equivalent to face-to-face pulmonary rehabilitation in terms of improvements in exercise capacity (six minute walk test) and health status (COPD Assessment Test [CAT]). Participants will be randomly allocated into an m-PR group (intervention, n=50) or face-to-face pulmonary rehabilitation group (control, n=50) in a 1:1 ratio favouring the m-PR group. The research trial will involve sites in NSW across the Northern Sydney Local Health District.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95946 0
A/Prof Zoe McKeough
Address 95946 0
Discipline of Physiotherapy, The University of Sydney
75 East St Lidcombe NSW 1825
Country 95946 0
Australia
Phone 95946 0
+61 2 93519269
Fax 95946 0
Email 95946 0
[email protected]
Contact person for public queries
Name 95947 0
Zoe McKeough
Address 95947 0
Discipline of Physiotherapy, The University of Sydney
75 East St Lidcombe NSW 1825
Country 95947 0
Australia
Phone 95947 0
+61 2 93519269
Fax 95947 0
Email 95947 0
[email protected]
Contact person for scientific queries
Name 95948 0
Zoe McKeough
Address 95948 0
Discipline of Physiotherapy, The University of Sydney
75 East St Lidcombe NSW 1825
Country 95948 0
Australia
Phone 95948 0
+61 2 93519269
Fax 95948 0
Email 95948 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
Ethics consent has not been gained for the sharing of individual data


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.