Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000884101
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
21/06/2019
Date last updated
22/01/2020
Date data sharing statement initially provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
mobile Pulmonary Rehabilitation - Determining the feasibility and acceptability of an adaptive mobile Pulmonary Rehabilitation (PR) programme
Scientific title
A Pilot study to assess the feasibility and acceptability of an adaptive mobile Pulmonary Rehabilitation (PR) programme to support people with chronic respiratory conditions.
Secondary ID [1] 298230 0
None.
Universal Trial Number (UTN)
U1111-1233-1491
Trial acronym
mPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 312828 0
Respiratory Conditions 312829 0
Condition category
Condition code
Respiratory 311327 311327 0 0
Chronic obstructive pulmonary disease
Respiratory 311393 311393 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive the mPR text message programme and can choose to also receive the mPR-app and/or mPR-sensor.

The mPR text message programme includes receipt of anywhere between 2-10 text messages per week, depending on the modules they select (up to 3 modules), that are aimed at motivating people to exercise and supporting people with PR related health behaviours. Participants also receive a tailored exercise programme as part of this study, which is selected by their PR clinician at sign up. The exercise programme will contain exercises associated with stretching, cardiovascular or aerobic and strengthening.

The mPR app programme includes PR related health information, a weekly exercise plan (same as the SMS exercise plan) selected by participants PR clinician at sign up, PR exercise videos (specifically created for this study), information on relaxation, a brief quality of life questionnaire and a built-in sit-to-stand test that participants can complete. Participants are asked to complete a sit to stand test and quality of life questionnaire every 2 weeks (if safe to do so). Outside of this request, participants are free to use the app as they wish. Participants who do not receive the app will still receive the exercise programme as part of the SMS component of the study.

The mPR sensor programme includes participants being asked to wear a commercially available smart sensing watch as they wish, over the trial period.

They will receive the intervention for 9 weeks. At the end of the programme all participants (including those that withdraw) will be asked to complete questions about their satisfaction with the programme, its perceived usefulness and usability, and perceived positive impacts, via a semi-structured telephone or online survey.

Engagement with the intervention will be assessed at the end of the trial using self-reports and system-recorded measures including SMS responses, sensor data, and app data. Change in exercise capacity and health-related quality of life will also measure where there is available data. In addition, participants will consent to the research team obtaining their healthcare utilisation data including emergency department (ED) visits and hospitalisations (number and duration) during the study period from their health records.
Intervention code [1] 314471 0
Rehabilitation
Intervention code [2] 314472 0
Lifestyle
Intervention code [3] 314521 0
Treatment: Devices
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320058 0
Exercise Capacity using a 6-minute walking test at baseline vs. post-intervention with the participants PR clinician.
Timepoint [1] 320058 0
Day 1 of intervention vs 7 days post-intervention completion
Secondary outcome [1] 370385 0
Hospitalisations using study-specific questionnaire and health records.
Timepoint [1] 370385 0
At end of trial period
Secondary outcome [2] 370700 0
Engagement via questionnaire specifically designed for this study.
Timepoint [2] 370700 0
Within 3 weeks post-intervention completion
Secondary outcome [3] 370701 0
Usability via questionnaire specifically designed for this study.
Timepoint [3] 370701 0
Within 3 weeks post-intervention completion
Secondary outcome [4] 370702 0
acceptability via questionnaire specifically designed for this study.
Timepoint [4] 370702 0
Within 3 weeks post-intervention completion
Secondary outcome [5] 370703 0
Quality of Life using EQ-5D questionnaire
Timepoint [5] 370703 0
Within 3 weeks post-intervention completion

Eligibility
Key inclusion criteria
- Aged 16 years or older
- Have a chronic respiratory disease e.g. COPD
- Eligible for PR
- Referred by a PR clinician
- Able to read and understand English
- Able to provide informed consent
- Own or have regular access to a mobile phone
Minimum age
16 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

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
Other
Other design features
Within the single group, there are 3 different options of the intervention the participant may select.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2019
Actual
30/07/2019
Date of last participant enrolment
Anticipated
1/07/2019
Actual
23/08/2019
Date of last data collection
Anticipated
6/09/2019
Actual
8/11/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21476 0
New Zealand
State/province [1] 21476 0

Funding & Sponsors
Funding source category [1] 302768 0
Government body
Name [1] 302768 0
MedTech CoRE
Country [1] 302768 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation - University of Auckland
Address
National Institute for Health Innovation

School of Population Health

The University of Auckland

Private Bag 92019

Auckland Mail Centre

Auckland 1142

NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 302708 0
None
Name [1] 302708 0
Address [1] 302708 0
Country [1] 302708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303365 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 303365 0
Ethics committee country [1] 303365 0
New Zealand
Date submitted for ethics approval [1] 303365 0
31/05/2019
Approval date [1] 303365 0
21/06/2019
Ethics approval number [1] 303365 0
19/NTA/74

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

Contacts
Principal investigator
Name 93418 0
Dr Robyn Whittaker
Address 93418 0
National Institute for Health Innovation

Level 4, School of Population Health

Tamaki Campus

The University of Auckland

261 Morrin Road, Glen Innes

Auckland 1072

NEW ZEALAND
Country 93418 0
New Zealand
Phone 93418 0
+64 9 373 7599
Fax 93418 0
Email 93418 0
r.whittaker@auckland.ac.nz
Contact person for public queries
Name 93419 0
Taria Tane
Address 93419 0
National Institute for Health Innovation

Level 4, School of Population Health

Tamaki Campus

The University of Auckland

261 Morrin Road, Glen Innes

Auckland 1072

NEW ZEALAND
Country 93419 0
New Zealand
Phone 93419 0
+64 210600025
Fax 93419 0
Email 93419 0
taria.tane@auckland.ac.nz
Contact person for scientific queries
Name 93420 0
Taria Tane
Address 93420 0
National Institute for Health Innovation

Level 4, School of Population Health

Tamaki Campus

The University of Auckland

261 Morrin Road, Glen Innes

Auckland 1072

NEW ZEALAND
Country 93420 0
New Zealand
Phone 93420 0
+64 210600025
Fax 93420 0
Email 93420 0
taria.tane@auckland.ac.nz

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
SourceTitleYear of PublicationDOI
Dimensions AIMobile Pulmonary Rehabilitation: Feasibility of Delivery by a Mobile Phone-Based Program2021https://doi.org/10.3389/fcomp.2021.546960
N.B. These documents automatically identified may not have been verified by the study sponsor.