Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000457448
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A comprehensive DIGITAL solution To Empower Asthma and comorbidity self-Management. The DIGITAL TEAM study.
Scientific title
The effectiveness and cost effectiveness of a centralised, national digital asthma care program compared to enhanced usual care: A randomised controlled tele-trial.
Secondary ID [1] 314156 0
None
Universal Trial Number (UTN)
Trial acronym
DIGITAL TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 336989 0
Condition category
Condition code
Respiratory 333450 333450 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will receive the DIGITAL TEAM program, comprising various avenues of digital health such as tele/video consultations, text messages, mobile/web applications, email support and self-help materials, which a trained Asthma Educator will facilitate. The intervention follows a treatable traits model of care (i.e., addressing digitally measurable/treatable and clinically relevant conditions associated with asthma). The main components of the DIGITAL TEAM program are described below;  

• Telehealth consultations: An Asthma Educator will deliver at least two education sessions with the participant via video and/or audio telehealth platforms. . The first two telehealth consultations will take place within three months post randomisation at a time that is convenient to the participant and educator. Subsequent telehealth sessions will take place as needed, at a time that is convenient, as determined in consultation between the participant and educator (for example, the participant may benefit from another follow-up on the inhaler device use technique). These sessions will provide education, self-management strategies, and address asthma-related treatable traits/comorbidities. The Asthma Educator will be trained in motivational interviewing and behavioural change techniques, as well as the necessary educational information and best practice management strategies for related comorbidities/treatable traits (e.g., smoking, gastroesophageal reflux, rhinitis, allergy, obesity, etc.). The digital platforms will be familiarised with the participants during these teleconsultation sessions. The Asthma Educators will maintain a record (study-specific logbook) of participants who attended the telehealth sessions. These records will be audited to assess the number of sessions attended.

• Study doctor: Participants will be referred to the study doctor after the first telehealth consultation, if additional support is required. For example, an asthma action plan (AAP) needs to be developed, medications need to be reviewed, and prescription medications are required for the treatable traits. Referrals will be actioned within 2 weeks. The study doctor will maintain a record (study-specific logbook) of participants who attended the consultations. These records will be audited to assess the timing/number of sessions attended.

• Mobile smartphone application: An interactive and personalised self-help mobile smartphone application (App) will be developed for the trial, prior to first participant enrolment, in consultation with people living with asthma and a variety of experts (clinicians, pharmacists, nurses, engineers, digital media professionals, marketing professionals, and software developers). The process of development includes convening a Consumer Reference Group, conducting focus groups and interviews with people with asthma, surveying Asthma Australia Asthma Educators, consulting with clinicians directly interacting with people with asthma, and consulting behavioural scientists to identify the requirements and risks for the design of this intervention. The App will provide:
- asthma education in the form of articles, written by experts from the Hunter medical research institute and asthma Australia. These articles will include images, infographics, and videos created by the above experts, and links to credible sources such as peer-reviewed articles, Quitline, Lifeline, Asthma Australia, The Severe Asthma Toolkit, and the Asthma in Pregnancy Toolkit.,
- facilitate medication adherence (via reminder function),
- correct inhaler technique (via videos),
- treatable trait self-management via a symptom diary, trait education, and goal setting functions
- symptom/ exacerbation tracking, and
- provide warnings via notifications and/or text message (e.g., environmental triggers, etc.).
Participants are expected to engage with the app as needed to sufficiently manage their asthma. This is predicted to be a minimum of one interaction per week for 12 months. Participants can opt to use one or all functions of the app, at their discretion. De-identified usage analytics will be collected and used to determine adherence to app and web-app usage and functions used over the 12 months of the study.

• Text messages: The text message service will provide an alternative method of providing education and self-management strategies in two ways. General campaign messages on asthma (such as knowledge, adherence, device technique, etc.) and personalised targeted messages on treatable traits (such as tobacco smoking, rhinitis, reflux, obesity etc.) education and management. Messages will be personalised based on self-reported information collected from the participant in the digital platform during initial onboarding and profile editing and/or documented by the asthma educator in the first telehealth session. Messages will be sent to participants weekly for 12 months. Adherence to text messages will be determined during follow-up interviews where study-specific questions will determine self-reported use of text messages and preferences for the messages will be captured using specific questions.

• Web application: A web application that mimics the mobile smartphone application for individuals who prefer not to use a mobile smartphone application or use both platforms. This web application will be accessible by all participants using the same log-in mechanisms as required by the app. De-identified usage analytics will be collected and used to determine adherence to app and web-app usage and functions used over the 12 months of the study.
Intervention code [1] 330745 0
Treatment: Other
Intervention code [2] 331006 0
Treatment: Devices
Comparator / control treatment
Participants in the comparator arm will receive the enhanced usual care, which includes the provision of generic written asthma education materials and a recommendation to visit their GP for an assessment of their asthma and asthma management.
Control group
Active

Outcomes
Primary outcome [1] 341023 0
Evaluate asthma control of participants in the intervention arm compared to enhanced usual care over a 6-month follow-up period.
Timepoint [1] 341023 0
6-months post randomisation
Secondary outcome [1] 445840 0
Evaluate asthma control of participants in the intervention arm compared to enhanced usual care at each follow-up.
Timepoint [1] 445840 0
Assessed at baseline, 3-, 6- and 12-month post-randomisation.
Secondary outcome [2] 445842 0
Evaluate the difference in self-reported asthma exacerbations in the intervention arm compared to enhanced usual care.
Timepoint [2] 445842 0
Assessed at baseline, 3-, 6- and 12-month post-randomisation.
Secondary outcome [3] 445843 0
Evaluate asthma medication adherence in participants in the intervention arm compared to enhanced usual care.
Timepoint [3] 445843 0
Assessed at baseline, 3- and 6-months post-randomisation.
Secondary outcome [4] 445844 0
Evaluate health related quality of life of participants in the intervention arm compared to enhanced usual care.
Timepoint [4] 445844 0
Assessed at baseline and 6-month post-randomisation.
Secondary outcome [5] 445845 0
Evaluate inhaler device technique of participants in the intervention arm compared to enhanced usual care.
Timepoint [5] 445845 0
Assessed at baseline and 6-month post-randomisation.
Secondary outcome [6] 445846 0
Evaluate whether participants are undertaking study activities as intended and what activities are not undertaken as intended (fidelity).
Timepoint [6] 445846 0
Continuous data analytics over time until 12 months post randomisation.
Secondary outcome [7] 445847 0
Evaluate whether participants are undertaking study activities as intended and what activities are not undertaken as intended (fidelity).
Timepoint [7] 445847 0
Continuous data analytics over time until 12 months post randomisation.
Secondary outcome [8] 445848 0
Evaluate whether participants are undertaking study activities as intended and what activities are not undertaken as intended (fidelity).
Timepoint [8] 445848 0
Assessed at 6-months post-randomisation.
Secondary outcome [9] 445850 0
Evaluate the acceptability of the DIGITAL TEAM program.
Timepoint [9] 445850 0
Qualitative interviews conducted within 4 weeks after the 6-month follow-up. AIM is assessed at 6-months post-randomisation.
Secondary outcome [10] 445851 0
Evaluate the cost effectiveness of the DIGITAL TEAM program compared to enhanced usual care from the perspectives of the healthcare system
Timepoint [10] 445851 0
Assessed at baseline, 3-, 6-, and 12-months post-randomisation.
Secondary outcome [11] 447322 0
Evaluate the feasibility of the DIGITAL TEAM Program.
Timepoint [11] 447322 0
Qualitative interviews conducted within 4 weeks after the 6-month follow-up. FIM conducted 6- months post randomisation
Secondary outcome [12] 447327 0
Evaluate the appropriateness of the DIGITAL TEAM program.
Timepoint [12] 447327 0
Qualitative interviews conducted within 4 weeks after the 6-month follow-up. IAM conducted 6- months post randomisation
Secondary outcome [13] 447328 0
Evaluate participant satisfaction with the DIGITAL TEAM program.
Timepoint [13] 447328 0
Qualitative interviews conducted within 4 weeks after the 6-month follow-up.

Eligibility
Key inclusion criteria
• Adults with asthma (doctor diagnosis of asthma AND medication use for asthma in the last 12 months).
• Have access to a smart phone with the ability to connect to the internet.
• Able to understand and provide informed consent and willing to complete baseline and follow-up interviews.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to speak and understand the English language.
• Unable to provide informed consent.
• Currently undergoing telephone calls with the Asthma Australia Asthma Educators.
• Currently involved in any other respiratory studies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. The electronic data capture system, REDCap, will assign a unique randomisation number to all participants using a pre-generated concealed randomisation list embedded in the system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. The randomisation algorithm and allocation will be managed by an independent statistician.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2025
Actual
Date of last participant enrolment
Anticipated
30/10/2026
Actual
Date of last data collection
Anticipated
29/10/2027
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318666 0
Government body
Name [1] 318666 0
Medical Research Future Fund - Department of Health and Aged Care
Country [1] 318666 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321201 0
None
Name [1] 321201 0
Address [1] 321201 0
Country [1] 321201 0
Other collaborator category [1] 283487 0
Charities/Societies/Foundations
Name [1] 283487 0
Asthma Australia
Address [1] 283487 0
Country [1] 283487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317280 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317280 0
Ethics committee country [1] 317280 0
Australia
Date submitted for ethics approval [1] 317280 0
17/05/2024
Approval date [1] 317280 0
19/02/2025
Ethics approval number [1] 317280 0
H-2024-0146

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

Contacts
Principal investigator
Name 140550 0
Dr Dennis Thomas
Address 140550 0
University of Newcastle, Level 2 West, Lot 1, HMRI building, Kookaburra Cct, New Lambton Heights NSW 2305
Country 140550 0
Australia
Phone 140550 0
+61 2 4042 0199
Fax 140550 0
Email 140550 0
[email protected]
Contact person for public queries
Name 140551 0
Kirsty Murray
Address 140551 0
University of Newcastle, Level 2 West, Lot 1, HMRI building, Kookaburra Cct, New Lambton Heights NSW 2305
Country 140551 0
Australia
Phone 140551 0
+61 2 4042 0944
Fax 140551 0
Email 140551 0
[email protected]
Contact person for scientific queries
Name 140552 0
Dennis Thomas
Address 140552 0
University of Newcastle, Level 2 West, Lot 1, HMRI building, Kookaburra Cct, New Lambton Heights NSW 2305
Country 140552 0
Australia
Phone 140552 0
+61 2 4042 0199
Fax 140552 0
Email 140552 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.