Skip to content

Digi-Predict Asthma: Digital predictors of asthma attacks

Physiological, behavioral and environmental predictors of asthma exacerbations: a prospective observational study using digital sensors and artificial intelligence

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000764639
Acronym
DIGIPREDICT
Enrollment
300
Registered
2023-07-13
Start date
2023-07-31
Completion date
2025-08-01
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Asthma rates in New Zealand are among the highest in the world, particularly in Maori and Pacific. Asthma attacks, or exacerbations, are the leading cause of deaths. Attacks are highly preventable if detected early. Unfortunately, there are currently no reliable ways of predicting attacks. Evidence suggests that there are changes that occur physiologically and behaviourally in the days and weeks preceding an attack, but these are not readily identified without technology. This aim of this study is to use a smart technologies to better predict asthma attacks by collecting real-time data from smart technologies such as smart watches and smart inhalers, and combining with NZ health and environmental datasets. We will then use artificial intelligence (AI) to produce a risk prediction model. The study aims to recruit 300 people, aged 12-65 years, with a previous asthma exacerbation in the last 12 months. Participants will be recruited from primary and secondary care in two regions in New Zealand. Each participant will be given a smart watch, smart peak flow meter, smartinhaler, and cough monitor to use regularly over 6 months with fortnightly questionnaires on asthma control and wellbeing. The occurrence of asthma attacks will be detected by self-report when they occur and from clinical records. The collected data, along with environmental data on weather and air quality, will be analysed to develop a risk prediction model for asthma attacks. We will also measure participant acceptability of the devices at the end of the study.

Interventions

This study is a prospective observational study to identify risk factors of asthma exacerbations. There is no active intervention. Unlike a traditional observational study, we are not assessing an exposure of interest and assessing outcome, rather we are measuring a diverse range of physiological, behavioural and environmental factors to evaluate their relationship(s) with asthma exacerbations. These variables include medication data from dispensing records and smart inhalers; peak flow data fr

This study is a prospective observational study to identify risk factors of asthma exacerbations. There is no active intervention. Unlike a traditional observational study, we are not assessing an exposure of interest and assessing outcome, rather we are measuring a diverse range of physiological, behavioural and environmental factors to evaluate their relationship(s) with asthma exacerbations. These variables include medication data from dispensing records and smart inhalers; peak flow data from a bluetooth smart peak flow meter; nocturnal cough from a cough monitoring app on the participant's phone; and physiological variables (e.g. heart rate) collected by a smart watch. All smart devices will be provided to the study participants. Diet, asthma control and general wellbeing will also be assessed using participant questionnaires. There will be two study visits in person – one at baseline (enrolment) and one at 6 months. The visits can take place either at The University of Auckland Grafton campus or at the participant's place of residence or other nominated location, whichever suits the participant best. These will be conducted by a member of the research team. At the initial visit at start of the study, participants will be provided with the required smart devices and instructions and a demonstration of how to use these devices. It is expected that these study visits would take up to 2 hours. In between these visits, participants will have some short questionnaires to complete either self-completed online remotely or researcher-assisted over the phone every 2 weeks for 6 months post-enrolment. These will take up to 5-10 minutes to complete. For the smart devices - participants will be given: a smart inhaler, smart peak flow meter, and smart watch. Some participants - those who already use a spacer on a regular basis and are familiar with the small volume spacer device - will be offered a smart (digital) spacer to use also instead of a traditional spacer. This measures inspiratory flow and inhalation. These devices will need to be paired to the participant's smart phone and their relevant app downloaded for it to work. Most of the data from the smart devices will be gathered passively i.e., participants won’t need to do anything extra other than use the devices as normal with their inhaler(s) and using the peak flow meter daily instead of your usual peak flow meter. Participants will need to use the cough monitoring app each night. Participants may need to open the apps a few times a week to ensure the data syncs successfully between the devices and the phone. Participants will need to wear the smartwatch during sleep and during awake hours everyday. Exceptions are made for wearing the smart watch for example when charging the watch and when having a shower or when there is any discomfort. Participants will also receive a quick text or phone call each month (whichever they prefer) to see how they are doing with the technology and devices. Researchers can access the collected data from the devices from the devices which will sync data with the related apps. To allow transfer of data from the smart devices, Bluetooth will need to be switched on. To send the data (upload), participants need to connect to the internet a few times a week to allow the data to be uploaded. This study involves collection of a large amount of information using different technologies to help us build a model using artificial intelligence (AI) to predict when an asthma attack might occur. We will use a type of AI called machine learning to analyse the data collected to identify patterns related to asthma attacks. The collected data will be entered into a machine learning component external to participants. No AI data will be fed back to participants at this stage of the study.

Sponsors

The University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

(i) Have a physician diagnosis of asthma; (ii) Previous history of an asthma attack in the last 12 months as per ATS/ERS definitions(1); (iii) Currently managing asthma with either preventative or relief medication delivered via either a pressurized metered dose inhaler (pMDI), Turbuhaler™, Ellipta™ or other device compatible with the Hailie® range of digital inhaler sensors; (iv) Residing in Auckland or Rotorua, or able to travel to either of these places for the study visits; (v) Able to provide informed consent and be able to follow study procedures or protocols; (vi) Own or be willing to use a smartphone with Bluetooth capability that is compatible with the study devices and can host the study apps; (vii) Be available and able to use the technologies for a period of 6 months. Individuals on treatment with other concomitant asthma medication will be eligible for inclusion; and (viii) Aged 12 to 65 years at the time of presentation to hospital or referral. (1) Reddel HK, Taylor DR, Bateman ED, Boulet L-P, Boushey HA, Busse WW, et al. An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations. American Journal of Respiratory and Critical Care Medicine. 2009;180:59-99. doi: 10.1164/rccm.200801-060ST.

Exclusion criteria

(i) they have a diagnosis of lung disease other than asthma e.g. COPD, bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia; (ii) (ii) smoking history of >10 pack years; or (iii) (iii) have a significant health condition or disability affecting ability to follow study procedures or protocols.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026