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Trial registered on ANZCTR


Registration number
ACTRN12620001006932
Ethics application status
Approved
Date submitted
6/08/2020
Date registered
6/10/2020
Date last updated
15/09/2021
Date data sharing statement initially provided
6/10/2020
Date results information initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Anti-Inflammatory Reliever Tutorial (AIR-T) sub-study: Can an interactive comic tutorial help adult patients with asthma understand and adhere to an anti-inflammatory reliever therapy regimen? An embedded randomised controlled trial.
Scientific title
The Anti-Inflammatory Reliever Tutorial (AIR-T) sub-study: Can an interactive comic tutorial help adult patients with asthma understand and adhere to an anti-inflammatory reliever therapy regimen? An embedded randomised controlled trial.
Secondary ID [1] 301935 0
MRINZ/19/13: AT
Universal Trial Number (UTN)
U1111-1246-5446
Trial acronym
AIR-T
Linked study record
MRINZ/19/13 (ANZCTR # pending) is the parent study of MRINZ/19/13:AT

Health condition
Health condition(s) or problem(s) studied:
Asthma 318482 0
Condition category
Condition code
Respiratory 316482 316482 0 0
Asthma
Public Health 316904 316904 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AIR-T sub-study is a randomised controlled trial embedded within the AIR Algorithm Study (UTN: U1111-1246-5446), which is a single-centre study. We aim to recruit all 100 participants of the parent study. The AIR-T sub-study aims to find out if interactive online tutorial resources which introduce patients with asthma to an Anti-Inflammatory Reliever algorithm (AIR algorithm), a novel self-management treatment algorithm, can improve participant understanding of and adherence to this algorithm. The tutorials have been designed specifically for this sub-study. They consist of educational comics followed by interactive short quizzes which provide feedback, allowing participants in the intervention group to practice applying knowledge gained, and to correct misunderstanding. The tutorial material is divided into two sections:

Tutorial 1
Tutorial 1a covers the rationale of the AIR algorithm concept
Tutorial 1b covers when to seek medical help

Tutorial 2
Tutorial 2 covers how to self-manage care using the AIR algorithm

Participants will navigate the AIR tutorial independently via an iPad device during study visit 1 in week 1 (Tutorial 1a and 1b) and visit 3 in week 26 (Tutorial 2) at the trial site for the parent study. Each will take approximately 15 minutes. Participants must scroll through the comic and complete each quiz question in order to progress, ensuring the tutorial is reviewed. A study investigator will be available to help with any technical difficulties.

Participants in both groups will complete the quiz questions in isolation (without the educational comics or feedback) again at week 13 (Quiz 1a and 1b covering the respective tutorial information) and 39 (Quiz 2 covering the tutorial 2 information), in order to determine knowledge retention at 13 weeks post-intervention/control.
Intervention code [1] 318227 0
Treatment: Other
Comparator / control treatment
Participants in the control group do not receive the AIR tutorial during their visits. Instead, they will complete non-interactive versions of the quizzes used in the intervention group at the same time points. These will not provide feedback (as this is considered part of the teaching provided by the tutorial), allowing us to assess their understanding without further education.

Participants in both groups will complete the quiz questions in isolation (without the educational comics or feedback) again at week 13 (Quiz 1a and 1b) and 39 (Quiz 2), in order to determine knowledge retention at 13 weeks post intervention/control.
Control group
Active

Outcomes
Primary outcome [1] 324631 0
Participant understanding of AIR Tutorial 1 material, as determined by the proportion of participants who score correctly on Quiz 1b, question 1, on Week 1. This quiz has been designed specifically for this study to test the material covered in the tutorial, which has also been designed for this study.
Timepoint [1] 324631 0
Week 1, completed as part of the tutorial within which it is integrated for the intervention group. The control group will complete a non-interactive version of the quiz at the same point in the study visit, which does not provide feedback upon completion.
Secondary outcome [1] 385268 0
Participant understanding as determined by the proportion of participants who score correctly on Quiz 1a & 1b questions on Week 1. This quiz has been designed specifically for this study to test the material covered in the tutorial, which has also been designed for this study.
Timepoint [1] 385268 0
Week 1, completed as part of the tutorial within which it is integrated for the intervention group. The control group will complete a non-interactive version of the quiz at the same point in the study visit, which does not provide feedback upon completion.
Secondary outcome [2] 385269 0
Participant knowledge retention as determined by comparison of marginal proportions of participant’s who score correctly at Weeks 1 and 13, based on scores of study-specific knowledge from quiz 1a and 1b on each week.
Timepoint [2] 385269 0
Immediately and 13 weeks post-completion of AIR Tutorial 1
Secondary outcome [3] 385270 0
Proportion of participants in each group with high inhaler use episodes (>8 actuations in 24 hours), without medical review within 48 hours, from Week 1 to Week 52 in the parent study. Inhaler use will be determined by Turbu+ electronic monitors fitted to parent study inhalers. Medical review within 48 hours will be determined via participant self-report at study
visits, participant diaries and medical records
Timepoint [3] 385270 0
Data will be collected from the Turbu+ electronic monitors fitted to parent study inhalers, which are used from baseline until the study completes (week 52), and downloaded for review at the end of the study. Participants will be encouraged to report events when they happen in a provided diary and will discuss these at each 3-monthly study visit. Participants are asked to call the study team directly following medical management of any severe asthma attack. Medical record review takes place following participant reported events.
Secondary outcome [4] 385271 0
Participant feedback about the tutorial resources (intervention group only) at Week 1 via a study-specific questionnaire
Timepoint [4] 385271 0
Week 1 immediately post-completion of Tutorial 1.
Secondary outcome [5] 385272 0
Participant understanding as determined by the proportion of participants who score correctly on Quiz 2, question 2, on Week 26. This quiz has been designed specifically for this study to test the material covered in the tutorial, which has also been designed for this study.
Timepoint [5] 385272 0
Week 26 (parent study visit 3), immediately post-completion of Tutorial 2 for the intervention group, and at this same point in the study visit for the control group.
Secondary outcome [6] 385273 0
Participant understanding as determined by the proportion of participants who score correctly on each Quiz 2 question on Week 26. This quiz has been designed specifically for this study to test the material covered in the tutorial.
Timepoint [6] 385273 0
Week 26 (study visit 3), completed as part of Tutorial 2 within which it is integrated for the intervention group. The control group will complete a non-interactive version of the quiz at the same point in the study visit, which does not provide feedback upon completion.
Secondary outcome [7] 385274 0
Participant knowledge retention as determined by comparison of marginal proportions of participant’s who score correctly at Weeks 26 and 39, based on scores of study-specific knowledge from Quiz 2 on each week.
Timepoint [7] 385274 0
Immediately (week 26) and 13 weeks post-completion of AIR Tutorial 2 (week 39)
Secondary outcome [8] 385275 0
Proportion of participants in each group taking a number of actuations correct for their current treatment step from Week 26 to Week 52. Actuation use will be determined by electronic monitors fitted to the inhalers. The 'correct' number of actuations will be determined by ranges recommended in the AIR algorithm for each treatment step.
Timepoint [8] 385275 0
Data will be recorded via electronic monitors fitted to the study inhalers, from Week 26 to Week 52. This data will be downloaded and reviewed at the end of the study.
Secondary outcome [9] 385276 0
Proportion of participants in each group who change step appropriately as determined by
assessing inhaler use (determined by Turbu+ electronic monitors fitted to parent study inhalers) in the 4 weeks prior to participant-led treatment step changes. The 'correct' range of daily actuation use is determined in the AIR algorithm for each treatment step.
Timepoint [9] 385276 0
13 and 26 weeks after initiation of monthly participant-led treatment step changes (which correspond to week 39 and 52 respectively). This data will be downloaded and reviewed at the end of the study.
Secondary outcome [10] 385277 0
Difference in Confidence score on a VAS at Week 26 between intervention and control groups
Timepoint [10] 385277 0
Week 26 immediately post-intervention for the tutorial group, and at this same point in the study visit for the control group.
Secondary outcome [11] 385278 0
Difference in Confidence score on a VAS at Week 39 and 52
Timepoint [11] 385278 0
Week 26 immediately post-intervention for the tutorial group, and at this same point in the study visit for the control group. This is repeated for both groups at week 52.
Secondary outcome [12] 385279 0
Participant feedback about the tutorial resources (intervention group only) at Week 26 via a study-specific questionnaire
Timepoint [12] 385279 0
Week 26 immediately post-intervention

Eligibility
Key inclusion criteria
Participants recruited to the AIR Algorithm Study (adults aged 18-75 with a self-reported doctor’s diagnosis of asthma that have provided written informed consent).
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation concealment will be by a secure database, which contains the randomisation sequence. A participant's PIS allocation will only be revealed to the researchers when that participant is randomised via the electronic case report form (eCRF).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, stratified by asthma severity at enrolment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22809 0
New Zealand
State/province [1] 22809 0

Funding & Sponsors
Funding source category [1] 306349 0
Charities/Societies/Foundations
Name [1] 306349 0
Medical Research Institute of New Zealand
Address [1] 306349 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country [1] 306349 0
New Zealand
Funding source category [2] 306353 0
Commercial sector/Industry
Name [2] 306353 0
AstraZeneca Ltd
Address [2] 306353 0
Level 5, 15 Hopetoun St
Freemans Bay
Auckland 1011
Country [2] 306353 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 306861 0
None
Name [1] 306861 0
Address [1] 306861 0
Country [1] 306861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306559 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 306559 0
Ministry of Health
Health and Disability Ethics Committees
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 306559 0
New Zealand
Date submitted for ethics approval [1] 306559 0
09/07/2020
Approval date [1] 306559 0
20/08/2020
Ethics approval number [1] 306559 0

Summary
Brief summary
This is a randomised controlled trial embedded as a sub-study within the AIR Algorithm trial. The study is investigating whether an interactive comic tutorial can support adult patients with asthma in understanding and adhering to a novel Anti-Inflammatory Reliever (AIR) Algorithm for the treatment of adult asthma.

100 participants will be enrolled in the parent AIR Algorithm trial for 52-weeks, during which time they are assigned the AIR stepwise approach to the management of asthma. For the AIR Tutorial sub-study, these participants will be randomised to either receive the AIR tutorial throughout the study (intervention group), or not (control group).

During scheduled study visits 1 and 3 for the AIR Algorithm trial, participants will be presented with the AIR tutorial (intervention) or quiz only (control group) on an iPad device provided by the study team. This comprises of taught components followed by a quiz to practice using the knowledge gained. Tutorials will cover the rationale of the AIR algorithm concept, when to seek medical help, and how to self-manage care using the AIR algorithm.

Those in the control group will not receive the taught tutorial component, but will complete an identical quiz which consists of the same questions, to determine baseline understanding. This will not feature the quiz answers, which are considered a part of the interactivity and taught component of the tutorial, so that any differences observed in outcome measures can be ascribed to the use of the AIR Tutorial.

For both intervention and control groups, quiz scores will be recorded in REDCap along with other data for the main study. Adherence data from the main study will be used to evaluate adherence-based outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104286 0
Prof Richard Beasley
Address 104286 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 104286 0
New Zealand
Phone 104286 0
+6448050147
Fax 104286 0
Email 104286 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 104287 0
Dr Ciléin Kearns
Address 104287 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 104287 0
New Zealand
Phone 104287 0
+64 4 805 0239
Fax 104287 0
Email 104287 0
cilein.kearns@mrinz.ac.nz
Contact person for scientific queries
Name 104288 0
Dr Ciléin Kearns
Address 104288 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 104288 0
New Zealand
Phone 104288 0
+64 4 805 0239
Fax 104288 0
Email 104288 0
cilein.kearns@mrinz.ac.nz

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?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary