ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Respiratory

Other respiratory disorders / diseases

Respiratory

Asthma

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

At the end of the intervention. This maybe between 8 and 12 weeks after commencement.

Primary outcome [2]

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]

At the end of the intervention. This maybe between 8 and 12 weeks after commencement.

Secondary outcome [1]

Physical function will be measured with 6-min walk test (6WMT).

Timepoint [1]

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]

Changes in participant’s symptoms will be monitored by the COPD assessment tool (CAT).

Timepoint [2]

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]

Participant’s health related quality of life will be assessed with the EQ-5D tool.

Timepoint [3]

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]

Patient preference will be assessed by their choice of intervention at recruitment.

Timepoint [4]

Baseline

Secondary outcome [5]

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]

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]

Lower limb function will be assessed with the One minute sit to stand test (1-min STS).

Timepoint [6]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

MedTech Core Flagship Project

Address [1]

Auckland BioEngineering Institute
Private Bag 92019
Auckland Mail Centre
Auckland
1142

Country [1]

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]

University

Name [1]

University of Auckland

Address [1]

National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland
1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/02/2021

Approval date [1]

23/03/2021

Ethics approval number [1]

Summary

Brief summary

People living with a chronic respiratory condition, experience shortness of breath, fatigue and difficulty completing everyday tasks. The burden on the person, their family and the healthcare system is significant. Pulmonary rehabilitation (PR) is a highly effective, evidence based intervention for people living with a chronic respiratory condition which has been shown to reduce symptoms, improve quality of life, increase independence and is associated with a reduction in hospital admissions.
PR involves; exercise, education and behaviour change strategies. Participants usually attend a centre based programme twice per week for eight weeks. Despite the proven efficacy, referral, attendance and completion rates for PR are low. In NZ, it has been shown that less than 2% of the people who would benefit get referred to, or attend PR. Travel, transport, illness and lack of perceived benefit have been identified as barriers to attendance.
Alternative methods for delivering and supporting PR are important to increase opportunities for people with a chronic respiratory condition to achieve health benefits. One global trend to improve access to PR is through the use of technology or mHealth.
Our previous research has found high level of interest from end users and key stakeholders in an mHealth delivered PR programme. Early testing of an NZ designed and developed mHealth intervention (mPR) has shown it is an acceptable and feasible method of delivering PR. This study will evaluate participants preference and engagement with mPR, if it can achieve comparable results in important health outcomes and gather feedback on
the patient experience with this mode of delivery of PR.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Sarah Candy

Address

Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062

Country

New Zealand

Phone

+64 21 414908

Fax

[email protected]

Contact person for public queries

Name

Ms Sarah Candy

Address

Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062

Country

New Zealand

Phone

+64 21 414908

Fax

[email protected]

Contact person for scientific queries

Name

Ms Sarah Candy

Address

Colvin Complex
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
1062

Country

New Zealand

Phone

+64 21 414908

Fax

[email protected]

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 [email protected].

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10786	Study protocol					381479-(Uploaded-24-02-2021-09-18-24)-Study-related document.docx
10788	Informed consent form					381479-(Uploaded-24-02-2021-09-18-57)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			381479-(Uploaded-24-10-2022-17-01-09)-Basic results summary.docx
Plain language summary	No		The trial screened 129 participants and enrolled 1... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Impact of Patient Preference on Attendance and Completion Rates at Centre-Based and mHealth Pulmonary Rehabilitation: A Non-Inferiority Pragmatic Clinical Trial.	2023	https://dx.doi.org/10.2147/COPD.S408423

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

Trial Review

Documents added manually

Documents added automatically