Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000754448
Ethics application status
Approved
Date submitted
19/06/2025
Date registered
16/07/2025
Date last updated
16/07/2025
Date data sharing statement initially provided
16/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of a digital health app for self-management and telehealth support for high-risk asthma patients on the frequency of hospital visits
Scientific title
Asthma in the North: A pre-post evaluation of a digital health platform for self-management and virtual care on emergency department presentations in adults and children with severe asthma in Northern Adelaide
Secondary ID [1] 314266 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AITN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 337205 0
Condition category
Condition code
Public Health 333614 333614 0 0
Health promotion/education
Respiratory 333613 333613 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Physical and Informational Materials
The intervention involves the implementation of a digitally enabled asthma care model for children and adults with severe asthma. Each participant is provided with a home monitoring kit containing a peak flow meter, a spacer, and a mask, which are delivered either during hospital admission, by courier, or by an AITN team member. Participants are also encouraged to purchase their own pulse oximeter for home use. Access to the CareMonitor platform requires an internet-connected device such as a smartphone, tablet, or computer. Participants can access the platform from home or any location with internet access, including community settings such as libraries, to enter symptom data, receive alerts, and access educational content. Educational resources from Asthma Australia provided through the platform include guidance on inhaler technique, asthma self-management strategies, and information about the asthma action plan used to categorise symptom severity. Each participant’s asthma action plan is developed or reviewed by a junior doctor and respiratory physician or paediatrician, and then transcribed into the digital platform by a respiratory nurse. CareMonitor is a secure, cloud-based digital health platform used to support remote patient monitoring, care coordination, and symptom tracking. It is integrated into the Northern Adelaide Local Health Network’s virtual care infrastructure (VIVA platform) and accessible via smartphone, tablet, or web browser.

Procedures, Activities, and Support Processes
Following enrolment and consent via REDCap, each participant attends a nurse-led onboarding session, which may be conducted in person at Lyell McEwin Hospital, Modbury Hospital, or via telehealth, depending on participant preference. During this session, the nurse collects baseline demographic and clinical data, administers validated questionnaires, and provides education on how to use the CareMonitor app and the home monitoring kit Participants are instructed to log their asthma symptoms into CareMonitor at least once per week or whenever their symptoms change. They select the level of their Asthma Action Plan that best reflects their current condition (well-controlled, flare-up, severe, or emergency). The app reinforces the participant’s Asthma Action Plan by providing tailored guidance on what actions to take, supporting self-management without requiring immediate clinician input. If a participant selects a level indicating worsening symptoms, a clinical alert is generated and reviewed by an AITN respiratory nurse within one business day. Alerts are reviewed by an AITN respiratory nurse within one business day. The nurse responds through a phone or video consultation to assess the participant’s clinical status, provide education, reinforce adherence to the asthma action plan, and, if required, escalate care. This may involve arranging a GP or respiratory physician consultation, referring to an urgent care centre, or activating emergency services. In addition to symptom monitoring, participants receive fortnightly asthma control questionnaires via the CareMonitor app. Responses are reviewed by the clinical team, with follow-up initiated if a participant reports symptom worsening or fails to respond. At the end of the six-month period, participants complete a final set of outcome questionnaires, and a summary of their involvement is sent to them or their parent/guardian.

Intervention Providers and Expertise
The intervention is delivered by a multidisciplinary team. The AITN respiratory nurses are trained in asthma education, digital platform use, and escalation protocols, and are responsible for onboarding, monitoring, and patient follow-up. Junior doctors and respiratory physicians or paediatricians oversee the development and review of each participant’s asthma action plan.

Mode of Delivery
Care is delivered through a hybrid model. Most interactions occur remotely, either through the CareMonitor app or via telehealth using phone or video calls. In-person interactions may occur when clinically indicated or when preferred by the participant, particularly during onboarding or action plan development. All care is delivered individually rather than in group sessions.

Frequency and Duration The intervention is designed to run over a six-month period for each participant. At the start, participants complete a single onboarding session lasting between 30 and 60 minutes, which may be conducted either in person or via telehealth. They are expected to log their asthma symptoms into the CareMonitor platform at least once per week, or more frequently if symptoms change or worsen. Throughout the study period, participants continue engaging with the platform by completing fortnightly asthma control questionnaires and regularly updating their symptom data. In addition to these routine interactions, further follow-up may occur whenever clinically necessary. If a participant enters symptom data that indicates worsening asthma control (amber, red, or emergency zone), the system automatically generates an alert. These alerts are reviewed by an AITN respiratory nurse within one business day (Monday to Friday, 8:00 AM to 5:00 PM). The nurse then contacts the participant by phone or video call to assess their condition, provide clinical advice, reinforce asthma education, and escalate care if required. Similarly, if a participant does not log any data for more than ten days, the clinical team will reach out to re-establish contact and ensure the participant's well-being.

Location of Delivery
The intervention is primarily delivered in the participant’s home through digital technology and telehealth. In-person visits occur at NALHN-affiliated health sites, including Lyell McEwin Hospital, Modbury Hospital, and the Women’s and Children’s Hospital, depending on the participant’s clinical needs and preferences.
Intervention code [1] 330879 0
Treatment: Other
Comparator / control treatment
Participants serve as their own controls in a pre-post study design, with outcomes following the intervention compared to those from the 12-month period prior to enrolment."
Control group
Active

Outcomes
Primary outcome [1] 341239 0
Rate of asthma-related emergency department (ED) presentations
Timepoint [1] 341239 0
At 6 months post-enrolment (primary timepoint), compared to the annualised rate from the 12-month retrospective pre-enrolment period.
Secondary outcome [1] 448494 0
Self-management capability
Timepoint [1] 448494 0
6 months post-enrolment.
Secondary outcome [2] 449343 0
Children's asthma quality of life
Timepoint [2] 449343 0
Baseline and 6 months post-enrolment.
Secondary outcome [3] 446892 0
Asthma control
Timepoint [3] 446892 0
Baseline and fortnightly
Secondary outcome [4] 446899 0
Corticosteroids use
Timepoint [4] 446899 0
At 6 months post-enrolment, compared with the 12-month period prior to enrolment. Annualised rate will be calculated.
Secondary outcome [5] 448497 0
Number of severe exacerbations
Timepoint [5] 448497 0
Cumulative count over the 6-month intervention period
Secondary outcome [6] 449344 0
Caregiver's quality of life
Timepoint [6] 449344 0
baseline and 6 months post- enrolment
Secondary outcome [7] 446963 0
Adult asthma-related quality of life
Timepoint [7] 446963 0
Baseline and 6 months post-enrolment.
Secondary outcome [8] 448495 0
Annualised exacerbations requiring systemic corticosteroids during study
Timepoint [8] 448495 0
Over the 6-month intervention period
Secondary outcome [9] 448498 0
FEV1 as % predicted
Timepoint [9] 448498 0
Start of enrolment, period where patient has an event of exacerbation and completion of entire study.
Secondary outcome [10] 448496 0
Mortality
Timepoint [10] 448496 0
At 6 months post-enrolment

Eligibility
Key inclusion criteria
1) Diagnosis of asthma by a medical professional.
2) At least two episodes of unplanned presentation to any public hospital in SA for a respiratory problem in last 12 months.
3) aged greater than or equal to 12 months
4) Residing in NALHN catchment or presented for a respiratory problem in the last 12 months
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Complicating dominant non-asthma respiratory disease.
-Chronic type II respiratory failure.
-Currently enrolled in an asthma interventional study.
-Cognitive or physical impairment precluding engagement with online platform.
-Resident of a care facility.
-Insufficient English language proficiency to engage with the digital platform or complete study procedures
-Unable or unwilling to provide informed consent.

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 and Statistical Analysis Plan
There is no validated minimal clinically important difference (MCID) for unplanned asthma-related hospital presentations; however, a reduction of 20% in annual exacerbation rate is considered clinically relevant in randomised controlled trials. A sample size of 68 participants provides 90% power to detect a 20% reduction in annualised unplanned presentation rate with a two-tailed alpha of 0.05. To account for attrition and exclusion, the study will recruit 100 participants (50 adults and 50 children).

Analysis of covariance (ANCOVA), linear mixed models, and mixed effects logistic regression will be used to evaluate treatment effects on continuous, count, and binary outcomes, respectively. Analyses will be adjusted for known confounders, including age, baseline asthma severity, and comorbidities. The analysis will compare outcomes during the 6-month intervention period with the 12 months prior to enrolment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27848 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 27962 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [3] 28164 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 44376 0
5092 - Modbury
Recruitment postcode(s) [2] 44043 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 44154 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 318788 0
Charities/Societies/Foundations
Name [1] 318788 0
Asthma Australia
Country [1] 318788 0
Australia
Funding source category [2] 319159 0
Charities/Societies/Foundations
Name [2] 319159 0
The Hospital Research Foundation Group
Country [2] 319159 0
Australia
Primary sponsor type
Government body
Name
Northern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 321615 0
None
Name [1] 321615 0
Address [1] 321615 0
Country [1] 321615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317396 0
women's and children's health network human research ethics committee
Ethics committee address [1] 317396 0
Ethics committee country [1] 317396 0
Australia
Date submitted for ethics approval [1] 317396 0
22/05/2025
Approval date [1] 317396 0
12/06/2025
Ethics approval number [1] 317396 0
2025/HRE00069

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

Contacts
Principal investigator
Name 140926 0
Dr Dr Thomas Crowhurst
Address 140926 0
Lyell McEwin Hospital, North Adelaide Local Health Network, Haydown Rd, Elizabeth Vale SA 5112
Country 140926 0
Australia
Phone 140926 0
+61 0439 810 678
Fax 140926 0
Email 140926 0
[email protected]
Contact person for public queries
Name 140927 0
Michael Palmer
Address 140927 0
Lyell McEwin Hospital, North Adelaide Local Health Network. Haydown Rd, Elizabeth Vale SA 5112
Country 140927 0
Australia
Phone 140927 0
+61 08 8182 9000
Fax 140927 0
Email 140927 0
[email protected]
Contact person for scientific queries
Name 140928 0
Wittwer, Melanie
Address 140928 0
Lyell McEwin Hospital, North Adelaide Local Health Network. Haydown Rd, Elizabeth Vale SA 5112
Country 140928 0
Australia
Phone 140928 0
+61 08 8182 9000
Fax 140928 0
Email 140928 0
[email protected]

Data sharing statement
Will the study consider sharing 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.