None listed
Conditions
Brief summary
To improve education, medication adherence, and symptom monitoring in people with asthma, a comprehensive digital program To Empower Asthma and comorbidity self-Management (DIGITAL TEAM) has been developed, to be implemented by Asthma Australia. This randomised controlled tele-trial aims to explore how effective this program is in improving asthma outcomes for Australians with Asthma, compared to enhanced usual care. 850 adults with asthma will be recruited and randomised into one of two arms. Control arm participants will be provided with educational materials about asthma and a recommendation to see their GP. Intervention arm participants will be referred to Asthma Australia, who will provide access to the DIGITAL TEAM program, which includes 2+ telehealth sessions, a smartphone application, text messages and a website. Follow-up interviews will be conducted at 3-, 6-, and 12-months post-randomisation. The primary outcome of this study is Asthma Control over 6-months.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.