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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
Date results information initially provided
22/01/2020
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
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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.
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Secondary ID [1]
298230
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None.
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Universal Trial Number (UTN)
U1111-1233-1491
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Trial acronym
mPR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
312828
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Respiratory Conditions
312829
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Condition category
Condition code
Respiratory
311327
311327
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0
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Chronic obstructive pulmonary disease
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Respiratory
311393
311393
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314471
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Rehabilitation
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Intervention code [2]
314472
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Lifestyle
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Intervention code [3]
314521
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Treatment: Devices
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Comparator / control treatment
None.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Exercise Capacity using a 6-minute walking test at baseline vs. post-intervention with the participants PR clinician.
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Assessment method [1]
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Timepoint [1]
320058
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Day 1 of intervention vs 7 days post-intervention completion
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Secondary outcome [1]
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Hospitalisations using study-specific questionnaire and health records.
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Assessment method [1]
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Timepoint [1]
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At end of trial period
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Secondary outcome [2]
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Engagement via questionnaire specifically designed for this study.
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Assessment method [2]
370700
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Timepoint [2]
370700
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Within 3 weeks post-intervention completion
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Secondary outcome [3]
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Usability via questionnaire specifically designed for this study.
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Assessment method [3]
370701
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Timepoint [3]
370701
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Within 3 weeks post-intervention completion
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Secondary outcome [4]
370702
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acceptability via questionnaire specifically designed for this study.
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Assessment method [4]
370702
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Timepoint [4]
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Within 3 weeks post-intervention completion
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Secondary outcome [5]
370703
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Quality of Life using EQ-5D questionnaire
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Assessment method [5]
370703
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Timepoint [5]
370703
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Within 3 weeks post-intervention completion
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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
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Not available for the duration of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Within the single group, there are 3 different options of the intervention the participant may select.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
30/07/2019
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Date of last participant enrolment
Anticipated
1/07/2019
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Actual
23/08/2019
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Date of last data collection
Anticipated
6/09/2019
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Actual
8/11/2019
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment outside Australia
Country [1]
21476
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New Zealand
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State/province [1]
21476
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Funding & Sponsors
Funding source category [1]
302768
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Government body
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Name [1]
302768
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MedTech CoRE
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Address [1]
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School of Population Health, The University of Auckland
Private Bag 92019 Auckland 1142, New Zealand
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Country [1]
302768
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New Zealand
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Primary sponsor type
University
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Name
National Institute for Health Innovation - University of Auckland
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Address
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
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Country
New Zealand
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Secondary sponsor category [1]
302708
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None
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Name [1]
302708
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Address [1]
302708
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Country [1]
302708
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303365
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New Zealand Health and Disability Ethics Committee
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Ethics committee address [1]
303365
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133 Molesworth Street
Thorndon
Wellington 6011
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Ethics committee country [1]
303365
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New Zealand
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Date submitted for ethics approval [1]
303365
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31/05/2019
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Approval date [1]
303365
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21/06/2019
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Ethics approval number [1]
303365
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19/NTA/74
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Summary
Brief summary
This study aims to assess the feasibility, acceptability and usability of an adaptive mobile Pulmonary Rehabilitation
(PR) programme.
Specific study objectives include to investigate:
- The acceptability of the mPR intervention for the delivery of PR support to people with chronic respiratory
conditions
- How people engage with an mPR intervention including specific intervention components
- The feasibility of providing tailored exercise prescription via mHealth
- The preferences for mPR modalities i.e. SMS, apps and sensors among people with chronic respiratory
conditions
- The feasibility of using an app for exercise measurement and questionnaire administration within an mPR
programme
- Feedback on the utility of visualisation of the lungs
- Feedback on the potential utility of the use of a sensor and associated data within an mPR intervention.
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Trial website
https://nihi.auckland.ac.nz/ehealth-and-mhealth
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Robyn Whittaker
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Address
93418
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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
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Country
93418
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New Zealand
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Phone
93418
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+64 9 373 7599
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Fax
93418
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Email
93418
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[email protected]
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Contact person for public queries
Name
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Ms Taria Tane
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Address
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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
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Country
93419
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New Zealand
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Phone
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+64 210600025
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Fax
93419
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Taria Tane
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Address
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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
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Country
93420
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New Zealand
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Phone
93420
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+64 210600025
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Fax
93420
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Email
93420
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Mobile Pulmonary Rehabilitation: Feasibility of Delivery by a Mobile Phone-Based Program
2021
https://doi.org/10.3389/fcomp.2021.546960
N.B. These documents automatically identified may not have been verified by the study sponsor.
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