Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000365864
Ethics application status
Approved
Date submitted
25/02/2021
Date registered
31/03/2021
Date last updated
25/10/2022
Date data sharing statement initially provided
31/03/2021
Date results provided
25/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulmonary rehabilitation – a preference clinical trial of centre based and mHealth delivered rehabilitation.
Scientific title
Pulmonary rehabilitation – a preference clinical trial of centre based and mHealth delivered rehabilitation for people living with a chronic respiratory disease.
Secondary ID [1] 303520 0
Nil known
Universal Trial Number (UTN)
1111-1264-9454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic respiratory disease 320852 0
Condition category
Condition code
Respiratory 318673 318673 0 0
Chronic obstructive pulmonary disease
Respiratory 318674 318674 0 0
Other respiratory disorders / diseases
Respiratory 318675 318675 0 0
Asthma
Physical Medicine / Rehabilitation 318719 318719 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have the choice of which intervention group they wish to be in. They can opt for Group A - centre-based PR (standard care) or Group B - home based PR delivered with technology (mPR). All participants in both groups will undergo a baseline assessment and a centre. The baseline assessment follows standard PR practise.
Group A: will be described below as the comparator.
Group B: mPR
Participants who opt for the mPR will receive a technology delivered PR programme with content mapped from standard PR programmes and based on best practise guidelines (Alison, McKeough et al. 2017).
Materials – participants will use their own device (computer or smartphone) to access the mPR programme. For those who do not have access to a internet-enabled device, they will be given the option of a text messaging programme and a paper copy of mPR.

Procedures
The programme includes a core component of tailored exercise prescription consisting of aerobic, resistance and balance exercises. Information regarding the safe and effective technique of each exercise is demonstrated at assessment and also provided in written and video format. Exercise prescription is based on their initial assessment scores (6 minute walk test distance and breathlessness score (Medical research council scale (MRC)) with participants being stratified to four different exercise levels by the recruiting clinician. Participants are encouraged the work at an intensity equivalent to 3-4 on the modified BORG scale. Information regarding the BORG scale will be provided in the mPR-app and in a paper manual. The programme is adaptive to patients current health state via; offering alternative exercises if participant are unable to complete the prescribed activity, allowing participants to pause the programme if they are unwell via a question at the end of the week if they are ready to progress their exercise.
Participants can monitor their progress in the mPR-app which displays the number of exercises completed each day.

Where appropriate, participants will be asked if they would like to wear a sensor for the eight-week period. The mPR-sensor used in this component of the study will be a commercially available Fitbit or Withings smartwatch, which monitors step count. This will be provided to participants. Participants who already use a sensor can integrate the data with their own sensor to the mPR-app. Participants will be asked to wear the mPR-sensor as they wish over the eight-week period and will be shown how to use the accompanying app at registration. Daily step count and weekly average step count data will be displayed on the My Progress page of the mPR-app. Step count data from the sensor will be accessed at the end of the study as well as usage data (how the sensor was used and how often).

The mPR programme also includes 12 self-management education modules titled ‘tips and tools’ Each module includes written information, a short video clip and links to further information. The information can be accessed at any time and is designed to help participants to manage their health condition. The information is supported through daily text messges sent to participants. The modules are mapped from the education component of centre-based PR sessions.


Who
The mPR intervention has been designed and developed by a team of clincians and researchers with extensive experience in delivering PR and mHealth interventions. The content has been mapped from PR best practise guidelines (Alison, McKeough et al. 2017)
The recruiting clinician will be an experienced physiotherapist (> 3 years clinical experience)from the PR team.

Mode of delivery
The programme can be delivered in a variety of formats. All participants will receive daily text messaging. All core information will be sent in the text messages. The mPR-app can be accessed on participants own computer or smartphone. If they do not have access to a device, the information will be provided in a written manual.

Number of times
Participants are asked to complete the prescribed exercise programme 5 x per week for 8 weeks. The exercise programme will take between 30 – 45 minutes to complete. Each week participants will be asked if they are ready to progress their exercise programme. If yes, a slightly increased exercise programme will be delivered, if answer no, the same exercise programme is repeated.
Participants will have the option to pause the programme if unwell. The programme can be extended up to 12 weeks.


Location
Participants will complete in their own home.

The exercise programme is personalised based on assessment findings. The exercise programmes are stratified to four levels. The exercise level prescribed will be determined by the recruiting physiotherapist and will be based on distance walked on six minute walk test, breathlessness score MRC). The text messaging content contains core modules for all participants, and optional modules which are discussed with the participant at recruitment. These include; smoking cessation, information to assist with secretion clearance, information for people with low body mass index(BMI).

The programme has been designed to monitor adherence with exercise by 2-way messaging. Each week on day 7, a message will be sent asking the participant how many times they have completed their exercises that week. Participants are asked to reply with the number.
In addition, the number of exercises completed will be recorded. This information will be access from the mPR-app or alternatively paper activity diary for participants without a device. Daily text messages will provide information and motivation to encourage participants to keep up their exercise programme.
Intervention code [1] 319808 0
Rehabilitation
Intervention code [2] 319839 0
Behaviour
Intervention code [3] 319840 0
Lifestyle
Comparator / control treatment
Group A: Centre based Group
Participants who opt for the centre-based intervention will attend the centre two days per week for eight weeks. The intervention will include one hour of supervised exercise training in a group setting ( 8 – 14 participants) delivered by a physiotherapist and respiratory nurse and/or health care assistant. Exercise prescription includes aerobic, resistance and balance exercises individually prescribed and completed in a circuit programme. Intensity of exercise is prescribed based on the modified BORG scale with all participants encouraged to progress exercise to maintain a breathlessness score of 3 - 4. Participants will be provided with a home based exercise programme, which they are asked to complete three times per week and record in the provided activity diary. The number of sessions attended, the number of completed exercises circuits at the centre based site, and the number of exercises completed in the activity diary will be monitored. In addition, participants will be invited to attend a 30 minute group education session with focus on self-management education. Participants will be offered the opportunity to make up classes that may have been missed by extending the duration of PR up to 12 weeks if required. The centre based PR intervention follows standard clinical practise.
The programme is delivered at hospital outpatient clinic or community setting.

Control group
Active

Outcomes
Primary outcome [1] 326619 0
Attendance
Attendance at the centre based programme will be assessed based on the number of classes the participant attended (% of 16).
Attendance for the mHealth group (mPR) will be assessed via digital responses to two SMS questions per week. The percentage of return messages (% of 16).
A priori definition of pulmonary rehabilitation completion will be attending (in person or digitally) a minimum of 70% of the sessions (Williams, Lewis et al. 2014).
Timepoint [1] 326619 0
At the end of the intervention. This maybe between 8 and 12 weeks after commencement.
Primary outcome [2] 326620 0
Self-reported adherence to the exercise programme
The adherence to the prescribed exercise prescription will be assessed by the number of times participants completed >50% of the prescribed exercise prescription for that day.
Each participant will be given an exercise prescription to complete five days of the week.
The centre-based group will complete two supervised sessions and three home based sessions. The number of completed exercises will be obtained from the PR centre exercise circuit card and the activity diary provided for home based exercises.
The mHealth group will complete five home based sessions. The number of completed sessions will be obtained from the mPR-app or from activity diaries provided to the group with SMS only.
Timepoint [2] 326620 0
At the end of the intervention. This maybe between 8 and 12 weeks after commencement.
Secondary outcome [1] 392160 0
Physical function will be measured with 6-min walk test (6WMT).
Timepoint [1] 392160 0
The outcome measure will be assessed twice. Firstly at baseline and then secondly at completion of the program (between 8 - 12 weeks post intervention commencement).
Secondary outcome [2] 392161 0
Changes in participant’s symptoms will be monitored by the COPD assessment tool (CAT).
Timepoint [2] 392161 0
The outcome measure will be assessed twice. Firstly at baseline and then secondly at completion of the program (between 8 - 12 weeks post intervention commencement).
Secondary outcome [3] 392162 0
Participant’s health related quality of life will be assessed with the EQ-5D tool.
Timepoint [3] 392162 0
The outcome measure will be assessed twice. Firstly at baseline and then secondly at completion of the program (between 8 - 12 weeks post intervention commencement).
Secondary outcome [4] 392163 0
Patient preference will be assessed by their choice of intervention at recruitment.
Timepoint [4] 392163 0
Baseline
Secondary outcome [5] 392164 0
Participant satisfaction will be assessed with a study-specific questionnaire. Participants can complete this on paper or electronically at time of the follow up assessment or at home and post the questionnaires back. The questionnaires will be de-identified.
Timepoint [5] 392164 0
The participants will be asked to complete a questionnaire once at completion of the intervention, which maybe between 8 - 12 weeks following commencement.
Secondary outcome [6] 392239 0
Lower limb function will be assessed with the One minute sit to stand test (1-min STS).
Timepoint [6] 392239 0
The outcome measure will be assessed twice. Firstly at baseline and then secondly at completion of the program (between 8 - 12 weeks post intervention commencement).

Eligibility
Key inclusion criteria
- Aged 18 years or older
- Have a chronic respiratory disease e.g. COPD
- Eligible for PR (according to the recruitment site’s existing protocols)
- Able to read and understand English
- Able to provide informed consent
- mPR group only must own or have regular access to a mobile phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not available for the duration of the study
- Completed PR within past one year

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Patient preference assignment
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations
Two sample proportion test for Non-Inferiority trial was used to produce the sample size which demonstrates that the mPR intervention is not worse (equivalent or better) than the centre-based within an acceptable level to be worse known as the margin of error (Wang, Zhang et al. 2003). Sample size was calculated for each of the outcomes based on 80% and 90% and accounting for a drop-out rate of 10%. Based on an average completion rate of 60% with 30% difference and 5% margin of error and 80% power, we would need a sample size of 50 in each group. Assuming a minimal important clinical difference of 30 metres of 6MWT and mean difference of 25 with a standard deviation of 5 and 80% power, we would be need 16 in each group. And based on CAT, we would need 32 in each group. The sample size needed was based on highest of the three outcomes, so total of 100 is needed (50 in each group).

Analysis
Baseline characteristics will be summarised using descriptive statistics. All data will be analysed by intention-to-treat.
Attendance - Attendance at 70% of sessions will be used as definition of completion. The proportion of participants who achieved this will be compared between groups using chi-squared tests.
Analysis of pre and post outcome measures will be analysed both intra group and between group using t tests.
Thematic analysis will be used to explore the patient satisfaction and feedback.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment had to stop due to COVID lockdowns and unable to see people face to face
Date of first participant enrolment
Anticipated
12/04/2021
Actual
9/06/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
17/08/2021
Date of last data collection
Anticipated
19/11/2021
Actual
9/12/2021
Sample size
Target
100
Accrual to date
Final
106
Recruitment outside Australia
Country [1] 23483 0
New Zealand
State/province [1] 23483 0
Auckland

Funding & Sponsors
Funding source category [1] 307940 0
Other Collaborative groups
Name [1] 307940 0
MedTech Core Flagship Project
Country [1] 307940 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Health & Rehabilitation Research Institute
Faculty of Health and Environmental Sciences
AUT University
90 Akoranga Drive
Northcote
Auckland
0627
Country
New Zealand
Secondary sponsor category [1] 308659 0
University
Name [1] 308659 0
University of Auckland
Address [1] 308659 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland
1142
Country [1] 308659 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307935 0
Health and Disability Ethics Committee
Ethics committee address [1] 307935 0
Ethics committee country [1] 307935 0
New Zealand
Date submitted for ethics approval [1] 307935 0
22/02/2021
Approval date [1] 307935 0
23/03/2021
Ethics approval number [1] 307935 0

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

Contacts
Principal investigator
Name 108974 0
Ms Sarah Candy
Address 108974 0
Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062
Country 108974 0
New Zealand
Phone 108974 0
+64 21 414908
Fax 108974 0
Email 108974 0
scandy@middlemore.co.nz
Contact person for public queries
Name 108975 0
Sarah Candy
Address 108975 0
Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062
Country 108975 0
New Zealand
Phone 108975 0
+64 21 414908
Fax 108975 0
Email 108975 0
scandy@middlemore.co.nz
Contact person for scientific queries
Name 108976 0
Sarah Candy
Address 108976 0
Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062
Country 108976 0
New Zealand
Phone 108976 0
+64 21 414908
Fax 108976 0
Email 108976 0
scandy@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The research team will consider reasonable requests for sharing of de-identified patient level data.
When will data be available (start and end dates)?
Current to 29/10/2026
Available to whom?
Case by case basis at the discretion of the Principle Investigator
Available for what types of analyses?
Only analyses related to the aims in the approval proposal.
How or where can data be obtained?
Access subject to approvals by Principle Investigator and completion of a data access agreement. Principle Investigator can be contacted via email at scandy@middlemore.co.nz.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10786Study protocol    381479-(Uploaded-24-02-2021-09-18-24)-Study-related document.docx
10788Informed consent form    381479-(Uploaded-24-02-2021-09-18-57)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Impact of Patient Preference on Attendance and Completion Rates at Centre-Based and mHealth Pulmonary Rehabilitation: A Non-Inferiority Pragmatic Clinical Trial.2023https://dx.doi.org/10.2147/COPD.S408423
N.B. These documents automatically identified may not have been verified by the study sponsor.