None listed
Conditions
Brief summary
Asthma attacks are common and can be life-threatening. They are a major cause of hospital admissions in New Zealand and affect Maori and Pasifika communities most severely. We know that changes in a person's physiology can signal an oncoming asthma attack days before it happens. Modern smartwatches can measure these signals continuously. The SENSAI trial will test whether a smartwatch-based alert system can help people take early action and reduce their number of asthma attacks. When participants receive an alert, they are prompted to follow their existing written asthma action plan. We will recruit 250 people aged 12 years and older who have been diagnosed with asthma and have had at least one asthma attack in the past year. Half will receive the active app with real-time risk alerts, and half will receive a similar app without the prediction feature. All participants will wear a consumer-grade smartwatch for 6 months. We will compare the number of asthma attacks, quality of life, and wellbeing between the two groups
Interventions
Brief name: DIGIPREDICT Study app incorporating DIGIPREDICT asthma attack risk prediction algorithm, created specifically for this study.
Materials: Participants receive a consumer-grade smartwatch for continuous physiological data collection. A dedicated study smartphone app (mobile or web app) is installed on the participant's own smartphone (or a study-provided phone where needed).
Procedures/algorithm: The app displays a daily personalised asthma attack risk estimate that is calculated bas
Brief name: DIGIPREDICT Study app incorporating DIGIPREDICT asthma attack risk prediction algorithm, created specifically for this study. Materials: Participants receive a consumer-grade smartwatch for continuous physiological data collection. A dedicated study smartphone app (mobile or web app) is installed on the participant's own smartphone (or a study-provided phone where needed). Procedures/algorithm: The app displays a daily personalised asthma attack risk estimate that is calculated based on smartwatch tracked physiological parameters such as activity, calories, sleep, step counts. An alert is triggered when the predicted risk is elevated relative to the participant's own personal baseline. On receiving an alert, participants are instructed to consult their existing written asthma action plan - this will be provided at study enrolment if participants do not have an existing plan. The app does not provide clinical advice or medication dosing recommendations. The participant interacts with the app by entering their asthma symptoms into the app and any asthma attacks that have occurred. When they receive an alert, they will also indicate on the app their perceived usefulness of the alert on a 1-5 Likert scale, and what action (if any) they are taking. Who delivers: The risk alert is delivered automatically by the study app. 10-minute standardised asthma education (inhaler technique review and written asthma action plan) is provided at enrolment by trained research staff either in-person or via video-conferencing, depending on whether the participant is enrolled in person or remotely. All research staff will attend an asthma education course delivered by Asthma NZ to ensure they have the necessary knowledge and skills to develop asthma action plans and asthma education. Monthly check-ins (phone, text, or email) are conducted by the research team to support adherence and monitor device function. Mode of delivery: Individual, remote/digital (smartphone app). Study visits are conducted in person at Auckland or Waikato clinical sites, or via video call. Schedule and duration: Continuous daily smartwatch wear and daily app use over 6 months. Formal assessments at baseline (Month 0), Month 3 (REDCap questionnaire), and Month 6 (final visit). Monthly check-ins at Months 1–5. Location: Participants' own daily environment (home, community). Adherence/fidelity: Smartwatch wear-time is checked by study staff. Monthly check-ins include a device function check. Wear-time adherence is a feasibility outcome.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 12 years or older. Physician-diagnosed asthma. History of at least one moderate or severe asthma attack in the past 12 months. Currently receiving care from a New Zealand health practitioner for asthma. Owns or is willing to use a compatible smartphone (a limited number of study phones are available). Available and able to use the technology for the 6-month study duration.
Exclusion criteria
Diagnosis of another chronic lung disease other than asthma. Smoking history of more than 10 pack years (self-reported). Currently pregnant. Currently enrolled in another clinical trial of an investigational medicinal product or medical device. Unable to provide informed consent. Note: concomitant asthma medications are permitted; participants may change, start, or stop treatments during the study.
Outcome results
None listed