Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000369820
Ethics application status
Approved
Date submitted
4/12/2020
Date registered
31/03/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
31/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The mobile Pulmonary Rehabilitation (m-PR) platform - user experience testing in patients with Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
Experience of and engagement with the mobile Pulmonary Rehabilitation (m-PR) platform in patients with Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 302713 0
None
Universal Trial Number (UTN)
Trial acronym
UETm-PR
Linked study record
This record is a study which precedes the clinical trial which has been indicated at ACTRN12619001253190.

Health condition
Health condition(s) or problem(s) studied:
COPD 319626 0
Condition category
Condition code
Respiratory 317567 317567 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The m-PR platform is the first Australian specific mobile health platform for people with chronic respiratory disease which allows patients to complete a home-based pulmonary rehabilitation program supported by technology. The m-PR platform contains both a patient app and a clinician web portal. The patient app contains daily symptom monitoring for up to 5 mins, a rehabilitation program of individualised exercises and education supported by videos which is undertaken three times per week for up to 1.5 hours, and health coaching through a bank of predictive text messages and a clinician portal which allows tracking of each patients progress.

The primary objective of this study is to determine the experience of using the mobile pulmonary rehabilitation (m-PR) platform to deliver home-based pulmonary rehabilitation in participants with Chronic Obstructive Pulmonary Disease (COPD). The experience of clinicians using the m-PR platform will also be examined.

Participants will receive a one-hour face-to-face education session on use of the m-PR app with the clinician. Participants will be asked to engage with the the m-PR app whist completing a home-based pulmonary rehab program. Participant tasks include daily symptom diary, recording of home exercise program adherence on the m-PR app and watching educational videos (such as about respiratory diseases, nutrition, smoking cessation, coping with breathlessness, airway clearance, respiratory medications, coping with anxiety and depression, physical activity). An individualised electronic COPD action plan (if prescribed by a doctor) will also be visible on the m-PR app and participants will be asked to complete the COPD Assessment Test (CAT) once a week via the m-PR app. A weekly telehealth session with clinicians will be provided for support and review of the home based pulmonary rehab program. Participants can use the m-PR app for up to 8 weeks.

Individual Elements in the app include the exercise training of aerobic and functional exercises which will be prescribed weekly through the clinician portal to the patient app after the weekly patient consultation. The exercises will include aerobic exercises of walking, treadmill or cycling plus a variety of functional exercises for the upper and lower limbs (e.g. sit to stand, stepping, squats, bicep curls). The goal setting will also be prescribed weekly for each person where as the action plan is uploaded at the beginning of the program reflecting the information prescribed by the doctor. An individualized program as described is necessary for the safety and delivery of the 8 week home-based pulmonary rehabilitation program.

Adherence to the app will be monitored through accessing app analytics (but this is not the primary objective of the project where the focus is on the opinions of the participants following app use).
Intervention code [1] 319161 0
Treatment: Devices
Intervention code [2] 319855 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325833 0
A semi-structured interview with participants (patients and clinicians) will be conducted. Each interview will be audiotaped and will take 30-45 minutes to complete. Interview questions will explore the participants overall experience and engagement with the m-PR program and will ask detailed questions about the individual components of the m-PR program. The usability of the m-PR platform, what worked well and did not work well with the platform will also be discussed and participants will be asked if they have any other recommendations for modification to the m-PR program
Timepoint [1] 325833 0
The interview will be undertaken within 2 weeks of the participant completing the m-PR program.
Secondary outcome [1] 389265 0
1) A study-specific survey has been created to determine satisfaction with the m-PR intervention. This survey consists of questions using a 5-point Likert scale and open-ended items.
Timepoint [1] 389265 0
Survey's will be undertaken within 2 weeks of the participant completing the m-PR program.
Secondary outcome [2] 389484 0
2) The System Usability Scale will be used to determine the usability of the m-PR platform. It consists of 10 statements where the participant will indicate their level of agreement/disagreement using a 5-point Likert scale.
Timepoint [2] 389484 0
Survey's will be undertaken within 2 weeks of the participant completing the m-PR program.

Eligibility
Key inclusion criteria
1. a) Adults aged over 40 years +
b) Stable COPD +
c) Referred to one of eight pulmonary rehabilitation programs at Royal North Shore Hospital, Ryde Hospital, Hornsby hospital, Brookvale Community Health Centre, Mona Vale Community Health Centre, Prince of Wales Hospital or Liverpool Hospital during the study period +
d) Access to, and capable of using, a smartphone +
e) Sufficient English: spoken and reading +
f) Willing to take part in the m-PR program at home

2) Clinicians coordinating the delivery of the m-PR program at the sites
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For the COPD participants:
1. had an acute exacerbation of COPD in the last month;
2. 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 (N.B. these are standard exclusion criteria as part of a pulmonary rehabilitation program which will be adhered to for this study);
3. supplemental oxygen requirements during testing or training procedures.
4. participated in any supervised exercise training within the last 12 months;
5. limited English language skills which might hinder their understanding of the m-PR platform or ability to read to the text;
6. limitations in access or 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
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)
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 size calculation – Ten participants with COPD were chosen to participate at each of the eight sites to provide a convenience sample upon which to do some user experience testing of the newly created m-PR platform before this platform is rigorously tested in a randomized controlled trial (RCT). It is anticipated that 80 participants will achieve data saturation.

Analysis plan – A combination of survey data and qualitative data from semi-structured face to face or telephone interviews with participants will be analysed. Survey data will be tallied to determine the level of acceptance and usability with the platform. Qualitative data will be transcribed and thematically analyzed to understand the experiences with the platform from the patient perspective which will then help to inform changes to the m-PR platform before rigorous testing in a RCT.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18099 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 18100 0
Ryde Hospital - Eastwood
Recruitment hospital [3] 18101 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [4] 18102 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 18103 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 18138 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [7] 18139 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [8] 19027 0
Brookvale Community Health Centre - Brookvale
Recruitment postcode(s) [1] 32087 0
2065 - St Leonards
Recruitment postcode(s) [2] 32088 0
2122 - Eastwood
Recruitment postcode(s) [3] 32089 0
2077 - Hornsby
Recruitment postcode(s) [4] 32090 0
2031 - Randwick
Recruitment postcode(s) [5] 32091 0
2170 - Liverpool
Recruitment postcode(s) [6] 32133 0
2103 - Mona Vale
Recruitment postcode(s) [7] 32134 0
2050 - Camperdown
Recruitment postcode(s) [8] 32150 0
2100 - Brookvale

Funding & Sponsors
Funding source category [1] 307123 0
Government body
Name [1] 307123 0
Northern Sydney Local Health District
Country [1] 307123 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 307698 0
Government body
Name [1] 307698 0
Northern Sydney Local Health District
Address [1] 307698 0
Northern Sydney Local Health District. The Lodge - Building 37, Macquarie Hospital, Cnr Twin and Badajoz Rds, North Ryde NSW 2113
Country [1] 307698 0
Australia
Other collaborator category [1] 281551 0
Individual
Name [1] 281551 0
Dr Marita Dale
Address [1] 281551 0
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country [1] 281551 0
Australia
Other collaborator category [2] 281552 0
Individual
Name [2] 281552 0
Dr Renae McNamara
Address [2] 281552 0
Organisation: Prince of Wales Hospital
Address: Physiotherapy Department, 320 Barker Street, Randwick, NSW, 2031
Country [2] 281552 0
Australia
Other collaborator category [3] 281553 0
Individual
Name [3] 281553 0
Dr Ling Ling Tsai
Address [3] 281553 0
Organisation: Prince of Wales Hospital
Address: Physiotherapy Department, 320 Barker Street, Randwick, NSW, 2031
Country [3] 281553 0
Australia
Other collaborator category [4] 281554 0
Individual
Name [4] 281554 0
A/Prof Lissa Spencer
Address [4] 281554 0
Organisation: Royal Prince Alfred Hospital
Address: Physiotherapapy Department 59 Missenden Rd Camperdown NSW 2050
Country [4] 281554 0
Australia
Other collaborator category [5] 281555 0
Individual
Name [5] 281555 0
A/Prof Sarah Dennis
Address [5] 281555 0
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country [5] 281555 0
Australia
Other collaborator category [6] 281556 0
Individual
Name [6] 281556 0
Ms Zoe Colman
Address [6] 281556 0
Organisation: Liverpool Hospital
Address: Physiotherapy Department, Cnr Elizabeth and Goulburn St, Liverpool, NSW, 2170
Country [6] 281556 0
Australia
Other collaborator category [7] 281557 0
Individual
Name [7] 281557 0
Dr Marlien Varnfield
Address [7] 281557 0
Organisation: Australian eHealth Research Centre
Address: Level 5 - UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital Herston QLD 4029
Country [7] 281557 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307235 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 307235 0
Ethics committee country [1] 307235 0
Australia
Date submitted for ethics approval [1] 307235 0
23/03/2020
Approval date [1] 307235 0
20/05/2020
Ethics approval number [1] 307235 0
2019/ETH14039

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

Contacts
Principal investigator
Name 106506 0
A/Prof Zoe McKeough
Address 106506 0
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country 106506 0
Australia
Phone 106506 0
+610293519269
Fax 106506 0
Email 106506 0
[email protected]
Contact person for public queries
Name 106507 0
Zoe McKeough
Address 106507 0
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country 106507 0
Australia
Phone 106507 0
+610293519269
Fax 106507 0
Email 106507 0
[email protected]
Contact person for scientific queries
Name 106508 0
Zoe McKeough
Address 106508 0
Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney

D18 – Susan Wakil Health Building, Western Ave, The University of Sydney, NSW, 2006
Country 106508 0
Australia
Phone 106508 0
+610293519269
Fax 106508 0
Email 106508 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


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.