Clinical trial NCT05594654: A Digital Respiratory Ecosystem for People Living With Asthma
Official title: A Digital Respiratory Ecosystem for People Living With Asthma: Mixed Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Asthma Research Group Windsor-Essex Inc
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2022-10-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty adults with a clinical diagnosis of asthma will be enrolled into this study.

Brief summary: The purpose of this pilot study is to establish the feasibility and acceptability of a digital respiratory ecosystem ("Breathe"), that incorporates an acoustic adherence algorithm, asthma/COPD differentiation classification algorithm, a smart inhaler cap, a digital spirometer, and a real-time air quality database to support people living with asthma to better manage their disease and derive personal and clinical value. Through this study, 30 adults will be asked to use Breathe as a way to monitor and manage their asthma symptoms over a 12-week period.

Detailed description: Asthma is one of the most common respiratory diseases globally and its prevalence is increasing. On average, 7.8% of Canadians were diagnosed with asthma in 2019. The direct and indirect impacts of asthma affects individuals physically, emotionally, and socially. As a chronic disease, the health and economic cost of asthma continues to grow. Asthma is a leading cause of disability and premature mortality in Canada. By 2030, it is estimated that asthma will cost Canadians more than $4 billion annually. Due to severe asthma exacerbations, there have been over 60,000 emergency room visits in 2019. However, these occurrences could have been averted with effective prevention and management measures. Several studies have indicated that only 50% of asthma patients in Canada are able to control the disease effectively.

In 2014, a digital respiratory application called Breathe was developed to support Canadians living with asthma. The first iteration of Breathe was developed as a self-monitoring and self-management web- and mobile-based application. Patients had access to their personal health information and electronic health records in order to understand their asthma care plan. The application shared asthma-related data with caregivers and health care providers to enhance the patient's asthma care. The features of the application were an action plan, daily and weekly symptom assessments, medication details, trend analyses, and alerting the patient of modifications in their asthma control zone.

Breathe 2.0 was adapted into a multi-functional iOS platform that offers dynamic and passive input through a chatbot, insights, predictions, and preventative measures to the user. These features included self-management asthma action plan, daily and weekly symptom assessment, and medication information, rich visualization of user data for review and trend analysis, and alerting functions to warn users of changes in their asthma control zone. In 2018, a randomized controlled trial of 138 patients was conducted with Breathe 2.0 to evaluate patient outcomes. This study concluded that individuals with asthma reported good usability and high satisfaction levels through the System Usability Scale. Furthermore, patients had high confidence in the platform's assessment of asthma control and the respective recommendations.

While Breathe 2.0 gave patients a platform to view and share information related to their symptoms, the app was cumbersome and required participants to manually enter their information; did not capture medication adherence which is an essential part of asthma symptom management, and did not incorporate spirometry insights into the algorithmic determination of asthma control.

This updated version of Breathe will be able to:

* Aid physicians in confirming the patient's diagnosis of Asthma or COPD through the use of the Asthma COPD differentiation classification algorithm
* Encourage and track medication adherence for both maintenance medications and use of rescue medications
* Educate users to recognize and manage their symptoms, and ensure they are adequately controlled
* Provide and promote the use of a customized action plan
* Monitor the use and effectiveness of the action plan
* Provide robust and granular weather, air quality and pollen forecasts to assist patients in identifying potential environmental triggers
* Introduce daily Spirometry testing and the importance of tracking and understanding Spirometry values and a "best number"

In this pilot study, investigators aim to evaluate the feasibility and acceptability of Breathe as a self-monitoring and self-management tool for asthma. Through this study, investigators seek to identify barriers to adoption and areas for improvement of the Breathe technology and to create a service model that will guide the implementation of this technology, allowing for a more widespread use of the intervention to be achieved.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Between 18 - 80 years of age
* Have a clinical diagnosis of asthma
* Received Global Initiative of Asthma (GINA) Step 3-5 asthma therapies to manage moderate to severe asthma
* Have been using Enerzair or Atectura maintenance medications for at least 2 weeks
* Currently prescribed a salbutamol rescue medication administered through a pressurized metered dose inhaler (MDI)
* Adequate English ability to complete study activities as determined by the study staff
* Own an iPhone that is compatible with the intervention (i.e. iPhone 7 or above, iOS 14 or above, and connected to an active data plan)

Exclusion Criteria:

* They are already under the care of a certified respiratory educator for uncontrolled asthma management
* They have another pulmonary disease (e.g. COPD) that will impact their ability to use the intervention as intended (as deemed by the recruiting clinician)
* They have a medical condition that would limit their ability to self-manage their asthma (as deemed by the recruiting clinician)

Primary outcomes:
measure: Patient Engagement
timeFrame: Measured at 12-weeks
measure: Component Engagement
timeFrame: Measured at 12-weeks
measure: Technical Issues
timeFrame: Measured at 12-weeks
Secondary outcomes:
measure: Changes in Patient's Inhaler Technique
timeFrame: Measured at continuously over 12- weeks; at baseline and at 12-weeks
measure: Changes in the quality of home spirometry
timeFrame: Measured continuously for 12-weeks and at 12-weeks
measure: Medication Adherence
timeFrame: Measured at 12-weeks
measure: Changes to asthma-related quality of life
timeFrame: Measured at Baseline and 12- weeks
measure: Changes to Asthma Control
timeFrame: Measured at Baseline, 12-weeks and continuously for 12-weeks
measure: Diagnostic Alignment
timeFrame: Measured at 12-weeks
measure: Changes to Satisfaction with Care
timeFrame: Measured at baseline and at 12-weeks
measure: Changes to Treatment Behaviour
timeFrame: Measured at Baseline and 12-weeks
measure: Changes to patient's healthcare utilization
timeFrame: Measured at Baseline and 12- weeks
measure: Maintenance Medication Adherence
timeFrame: Measured at 12-weeks
measure: Rescue Medication Use
timeFrame: Measured at 12-weeks
measure: Asthma Control
timeFrame: Measured at 12-weeks
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Asthma Research Group Windsor Essex County Inc
state: Ontario
Study officials:
References: