Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000603415
Ethics application status
Approved
Date submitted
8/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a Self-Management App for People with Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study
Scientific title
Feasibility of a Self-Management App for People with Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study
Secondary ID [1] 314307 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 337256 0
Condition category
Condition code
Respiratory 333660 333660 0 0
Chronic obstructive pulmonary disease
Public Health 333886 333886 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a one-arm pilot study where all participants will get access to one module of a self-management app for people with COPD. This module is an education and management of breathlessness module. All participants will get access to this module for two weeks where they will be able to use it as they wish to. This is a pre/post design, where participants will be completing questionnaires both before and after the use of the app.

The education module is designed to provide users with an understanding of COPD and breathlessness, as well as providing them with practical tools to help manage their symptoms. The education module explains what COPD is, the causes of breathlessness, and the science behind why it occurs and also introduces different therapeutic approaches for participants to try. It is split into three sections of what is COPD, common symptoms and other common concerns. Therapeutic approaches used within the module are evidence based in the COPD context include Cognitive Behavioural Therapy (CBT) (Heslop-Marshall et al., 2018; Heslop-Marshall & Burns, 2019), relaxation techniques (diaphragmatic breathing, pursed lop breathing, progressive muscle relaxation, visualisation) (Volpato et al., 2015) body positioning (Chan & Lehto, 2016) and some mindfulness. Throughout the module, relatable stories and visuals are used to help the user to connect to the content and relate it to their own life or situation.
Some parts of the module will be faster to complete than others. Within the one module that participants will have access to (the education module) there are three sections. What is COPD, Common symptoms and Other common concerns. Depending on the interests of the participant they may spend more time in one section than others due to it being more applicable to them. However, participants do not have to complete sections in one go. They can start a section and return to this if they get interrupted. Adherence to the app will not be enforced during the study however we will be observing how participants engage with the app and will be using this to determine feasibility. For example, completion rates, app usage, and participant retention. Completion rates will be measured by the proportion of participants who complete the sections within the app content provided. App usage will be assessed by tracking the frequency and duration of interactions participants have on the app, such as the number of logins, time spent using the app, and engagement with specific modules.
Intervention code [1] 330921 0
Treatment: Other
Comparator / control treatment
No control group - since it is a pilot study we are wanting to test the feasibility of the app for this population. Therefore all participants will be getting access to the same intervention (self-management app)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341249 0
Feasibility: Retention of participants
Timepoint [1] 341249 0
Retention will be measured after all participants have completed the study. The total number of participants who consented to participate will be compared to the number retained through to the study’s conclusion.
Primary outcome [2] 341250 0
Usability
Timepoint [2] 341250 0
Usability will only be assessed after they have used the app for two weeks
Primary outcome [3] 341251 0
Acceptability
Timepoint [3] 341251 0
Acceptability data will be collected after participants have had the app for two weeks
Secondary outcome [1] 446906 0
Stress
Timepoint [1] 446906 0
Timepoint one: before participant uses the app Timepoint two: after participant has used the app for 2 weeks
Secondary outcome [2] 446907 0
Quality of life
Timepoint [2] 446907 0
Timepoint one: before participant has access to the app Timepoint two: after participant has used the app for two weeks
Secondary outcome [3] 446909 0
Dyspnea - mMRC
Timepoint [3] 446909 0
Timepoint one: mMRC will be given before the participant has access to the app Timepoint two: mMRC will be tested again after the participant has had access to the app for two weeks
Secondary outcome [4] 447856 0
Feasibility - completion rates (primary outcome)
Timepoint [4] 447856 0
completion rates will be measured upon conclusion of everyone in the study using the app for two weeks.
Secondary outcome [5] 447857 0
Feasibility - App usage (primary outcome)
Timepoint [5] 447857 0
App usage data will be collected upon conclusion of the study once everyone has finished using the app for two weeks.
Secondary outcome [6] 447858 0
Activity - LCADL
Timepoint [6] 447858 0
Time point one: Before the individual starts the app Time point two: After the individual has finished their 2 week time period with the app
Secondary outcome [7] 447859 0
Activity - Step count
Timepoint [7] 447859 0
assessed after participant has completed their 2 week trial with the app to see how their activity was throughout the time they used the app.
Secondary outcome [8] 447860 0
Dyspnea - Borg CR10
Timepoint [8] 447860 0
Timepoint one: before they use the app Timepoint two: after participants have completed their two week trial of the app

Eligibility
Key inclusion criteria
The inclusion criteria for this study require participants to
1. Be diagnosed with COPD
2. Be well enough to take part
3. Be a minimum of 40 years of age
4. Reside in Auckland New Zealand
5. Be able to give informed consent
6. Own a smartphone and be capable of basic use and,
7. Be able to understand, read and write English
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude participants that are currently
1. Hospitalised
2. Practicing CBT, relaxation techniques, mindfulness or meditation regularly
3. Over 80 years old, and
8. Having severe COPD symptoms that would make it difficult to take part

Study design
Purpose of the study
Educational / counselling / training
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
14/11/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 27020 0
New Zealand
State/province [1] 27020 0

Funding & Sponsors
Funding source category [1] 318829 0
University
Name [1] 318829 0
University of Auckland
Country [1] 318829 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321277 0
None
Name [1] 321277 0
Address [1] 321277 0
Country [1] 321277 0
Other collaborator category [1] 283506 0
Commercial sector/Industry
Name [1] 283506 0
Fisher and Paykel Healthcare
Address [1] 283506 0
Country [1] 283506 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317445 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317445 0
Ethics committee country [1] 317445 0
New Zealand
Date submitted for ethics approval [1] 317445 0
20/03/2025
Approval date [1] 317445 0
03/04/2025
Ethics approval number [1] 317445 0
22358

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

Contacts
Principal investigator
Name 141054 0
Dr Anna Serlachius
Address 141054 0
University of Auckland, Building 507, Level 1 22-30 Park Road, Grafton , 1023
Country 141054 0
New Zealand
Phone 141054 0
+64 9 923 3073
Fax 141054 0
Email 141054 0
[email protected]
Contact person for public queries
Name 141055 0
Anna Serlachius
Address 141055 0
University of Auckland, Building 507, Level 1 22-30 Park Road, Grafton, 1023
Country 141055 0
New Zealand
Phone 141055 0
+64 9 923 3073
Fax 141055 0
Email 141055 0
[email protected]
Contact person for scientific queries
Name 141056 0
Anna Serlachius
Address 141056 0
University of Auckland, Building 507, Level 1 22-30 Park Road, Grafton, 1023
Country 141056 0
New Zealand
Phone 141056 0
+64 9 923 3073
Fax 141056 0
Email 141056 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data will only be used for a students masters thesis and publication and will not be made available to other researchers, uploaded to a database, or shared publicly. Only the research team will have access to the data. Participants will not be consenting to sharing data publicly.



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.