None listed
Conditions
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.
Interventions
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 algorith
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.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Exclusion criteria
None
Outcome results
None listed