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Trial registered on ANZCTR


Registration number
ACTRN12624000360516p
Ethics application status
Submitted, not yet approved
Date submitted
7/02/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial to evaluate a digital self-management and mental health intervention for young people with asthma and their families
Scientific title
Clinical trial to evaluate a digital self-management and mental health intervention for young people with asthma and their families
Secondary ID [1] 311486 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 332813 0
anxiety 333045 0
depression 333046 0
Condition category
Condition code
Respiratory 329527 329527 0 0
Asthma
Mental Health 329722 329722 0 0
Anxiety
Mental Health 329723 329723 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial of our Asthma AI+ smartphone application, comparing the AI+ features (Arm 1 – AI+ symptoms) to the symptom tracking only features (Arm 2 (control) – Symptoms). Intervention participants will be provided with a copy of a workbook along with the smartphone app.

Content development - Evidence-based content for use in the intervention platform (AI+ symptoms) will be produced to provide:
a. Education for young people with asthma and their families on understanding asthma how to recognise triggers, build coping skills for asthma exacerbations and other educational content aligned with national asthma guidelines,
b. Education for young people with asthma and families of children under 18 years of age, on understanding mental health and wellbeing, and how to build coping skills for symptoms of psychological distress associated with asthma,(e.g., symptoms of anxiety and depression),
c. Self-management skill development for asthma, informed by an individually tailored written action plan entered by the individual, or one developed in-app based on the individual’s data inputs and app interactions. This includes instructional videos on correct asthma inhaler technique, how to avoid triggers and manage exacerbations, and other best practice self-management strategies according to national asthma guidelines,
d. Psychologist delivered activities (via instructional videos and written content, interactive games, and self-help skill development modules), to support patients to self-manage episodes of psychological distress, build resilience and coping skills when experiencing flare-ups and to prevent worsening of symptoms,
e. 80-page downloadable workbook delivering written content, activities, and skill development for asthma and mental health/wellbeing, to supplement the digital intervention content. This will be developed based on best-practice asthma guidelines and through consultation with field experts in Psychology and Paediatric Respiratory Medicine. (Intervention participants will be provided with a copy of the workbook along with the smartphone app, while control group participants will only have access to the smartphone app for self-management.)

The AI and machine-learning algorithms proposed for this project utilise Just in Time Adaptive Intervention (JITAI) methodology, which allows content to be delivered at the right time for the user. The AI component will not interact with the user like other available AI programs, but instead will examine the user’s content usage, for example self-education modules, and deliver these when they are likely to be most useful to the user. This, along with gamification strategies, should encourage users to engage with the platform and get the most value from the content available.

Participants will be able to access and continue using the app to which they were randomised past the 12-week follow-up to 12 months, with questionnaires repeated periodically as per outcomes for the purposes of hypothesis generation and longitudinal follow-up. The app is to be used at the participants' discretion.

App use data will be forwarded to researchers.

The participant's parents/carers will also have access to a portal through which they can access content to help them care for a child with asthma, and, depending on age of the participant, will receive high level notifications when their child's data reflects that they are struggling with symptom management (either asthma or mental health).
Intervention code [1] 327936 0
Behaviour
Intervention code [2] 328075 0
Treatment: Other
Comparator / control treatment
Participants will be able to access and continue using the app to which they were randomised past the 12-week follow-up to 12 months, with questionnaires repeated periodically as per outcomes for the purposes of hypothesis generation and longitudinal follow-up. Control group participants will only have access to the smartphone app for self-management.
Control group
Active

Outcomes
Primary outcome [1] 337332 0
Change in asthma management
Timepoint [1] 337332 0
1 week, 4 weeks, 12 weeks (primary timepoint), 26 weeks, 52 weeks post enrolment.
Secondary outcome [1] 431467 0
Self-efficacy
Timepoint [1] 431467 0
12 weeks, 52 weeks post enrolment
Secondary outcome [2] 431468 0
Knowledge
Timepoint [2] 431468 0
12 weeks, 52 weeks post enrolment
Secondary outcome [3] 431469 0
Quality of life
Timepoint [3] 431469 0
12 weeks, 52 weeks post enrolment
Secondary outcome [4] 431470 0
Inhaler technique
Timepoint [4] 431470 0
1 week, 4 weeks, 12 weeks, 26 weeks, 52 weeks post enrolment
Secondary outcome [5] 431472 0
Symptoms of depression
Timepoint [5] 431472 0
12 weeks, 52 weeks post enrolment
Secondary outcome [6] 431474 0
Symptoms of anxiety
Timepoint [6] 431474 0
12 weeks, 52 weeks post enrolment
Secondary outcome [7] 431475 0
Hospital utilisation (length of stay)
Timepoint [7] 431475 0
12 weeks, 52 weeks post enrolment
Secondary outcome [8] 431476 0
Adverse events (e.g. increase in psychological distress symptoms)
Timepoint [8] 431476 0
1 week, 4 weeks, 12 weeks, 26 weeks, 52 weeks post enrolment
Secondary outcome [9] 431477 0
Cost effectiveness
Timepoint [9] 431477 0
52 weeks post enrolment
Secondary outcome [10] 431478 0
Medication adherence
Timepoint [10] 431478 0
1 week, 4 weeks, 12 weeks, 26 weeks, 52 weeks post enrolment
Secondary outcome [11] 432198 0
Cost benefit
Timepoint [11] 432198 0
52 weeks post enrolment
Secondary outcome [12] 432199 0
Hospital utilisation (ED visits)
Timepoint [12] 432199 0
12 weeks, 52 weeks post enrolment
Secondary outcome [13] 432200 0
Hospital utilisation (hospital re-admissions)
Timepoint [13] 432200 0
12 weeks, 52 weeks post enrolment

Eligibility
Key inclusion criteria
Young people aged 8-25 years with clinically diagnosed asthma, who have presented to WCH, LMH or FMC. Access to a smartphone with the owner’s permission to use it. Proficiency with a smartphone (or parent has proficiency), they are willing to have the app on their phone and have this device used for data collection and information transfer over at least the following 12-weeks. Are English speaking/able to understand written English.
Minimum age
8 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not meet the criteria above or cannot provide informed consent either via proxy or due to language or health limitations, or if aged under 16, parental consent not obtained, will not be eligible to participate.

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)
Automatically randomised via computer-based algorithms to intervention or control arms, with stratification across age categories, disease severity and ethnicity. Randomisation and allocation occurs within the app.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automatically randomisation via computer-based algorithms to intervention or control arms, with stratification across age categories, disease severity and ethnicity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
We will include two interim futility analyses within the research project, which essentially creates two 'go/no go' opportunities. This will allow earlier identification (within the first 12-months of the study), if the program is indeed tracking where we expect for effectiveness, safety and feasibility outcomes. These interim futility analyses provide an important opportunity to change tack which can optimise program effectiveness for young people with asthma, their families and HPs.
Data will be analysed for the primary and secondary 3-month efficacy, health economic, and scalability outcomes. The trial will be conducted in line with CONSORT pragmatic trial guidelines (36), with a pre-specified protocol registered. Dropouts or loss to follow-up will be compared between study arms, and against those remaining in the trial. For continuous outcome variables mixed effects linear models will be used. For other outcome measures mixed effects generalized linear models will be used. All models will adjust variables used in stratification via sub-group analysis. Impact of between-group contamination will be examined in sensitivity analyses. Multiple imputation will be undertaken if appropriate. Statistical analyses will be performed using Stata 15 on intention-to-treat basis, with statistical analyses led by Chair of Biostatistics & Epidemiology, Prof Esterman.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
2/10/2026
Actual
Date of last data collection
Anticipated
2/10/2027
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26156 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 42018 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 315773 0
Hospital
Name [1] 315773 0
Women's and Children's Hospital Foundation
Country [1] 315773 0
Australia
Funding source category [2] 315780 0
Other
Name [2] 315780 0
Houd Research Group
Country [2] 315780 0
Australia
Funding source category [3] 315781 0
Other
Name [3] 315781 0
Health Translation South Australia (HTSA)
Country [3] 315781 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 317897 0
None
Name [1] 317897 0
Address [1] 317897 0
Country [1] 317897 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314633 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 314633 0
Ethics committee country [1] 314633 0
Australia
Date submitted for ethics approval [1] 314633 0
06/02/2024
Approval date [1] 314633 0
Ethics approval number [1] 314633 0

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

Contacts
Principal investigator
Name 132226 0
A/Prof Kristin Carson-Chahhoud
Address 132226 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Country 132226 0
Australia
Phone 132226 0
+61 0412 708 879
Fax 132226 0
Email 132226 0
kristin.carson@adelaide.edu.au
Contact person for public queries
Name 132227 0
Mrs Kelsey Sharrad
Address 132227 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Country 132227 0
Australia
Phone 132227 0
+61 0412 708 879
Fax 132227 0
Email 132227 0
kelsey@houdresearch.com.au
Contact person for scientific queries
Name 132228 0
Kristin Carson-Chahhoud
Address 132228 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Country 132228 0
Australia
Phone 132228 0
+61 0412 708 879
Fax 132228 0
Email 132228 0
kristin.carson@adelaide.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21592Study protocol    To be published.



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.