A Digital Respiratory Ecosystem for People Living With Asthma

Asthma Clinical Trial

Official title:

A Digital Respiratory Ecosystem for People Living With Asthma: Mixed Methods

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05594654
• Other study ID #: ARGI-001
• Status: Active, not recruiting
• Start date: September 29, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Asthma Research Group Windsor-Essex Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Smart Phone Application
Breathe is an app that can be used by people with asthma to promote collaborative self-management. It is a platform that empowers patients to self-manage their condition. Breathe helps patients detect when they might be exacerbating or adequately controlled based on symptoms entered by the user into the application. The application then feeds these symptoms through a rules-based algorithm that identifies the early onset of an exacerbation, based on the user's "zone of control" or action plan. It also stores the patient's self-management action plan and gives them relevant instructions when it sees that their symptoms are getting better or worse. These instructions are delivered through a chatbot that provides information, support, and education to the patient through a friendly, human-like text message conversation.

Locations

Country	Name	City	State
Canada	Asthma Research Group Windsor Essex County Inc	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Asthma Research Group Windsor-Essex Inc	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Engagement	Number of unique days patient used the Breathe app	Measured at 12-weeks
Primary	Component Engagement	Assess by how often patients are using the different components of the breathe app.	Measured at 12-weeks
Primary	Technical Issues	Assess the number of technical issues reported.	Measured at 12-weeks
Secondary	Changes in Patient's Inhaler Technique	Assessed by the number of inhaler technique errors detected by in-app tool, in-app audio recording of medication inhaler and formal assessment of inhaler technique done in clinic.	Measured at continuously over 12- weeks; at baseline and at 12-weeks
Secondary	Changes in the quality of home spirometry	Assessed by the number of failed spirometry tests detected by in-app digital spirometer, formal assessment of unsupported test completed at clinic and patient experience feedback survey.	Measured continuously for 12-weeks and at 12-weeks
Secondary	Medication Adherence	Assessed by the electronic measures of adherence through the Breathe application.	Measured at 12-weeks
Secondary	Changes to asthma-related quality of life	Assessed by the Mini Asthma Quality of Life questionnaire. This questionnaire contains 15-questions that asses the quality of health-related well-being for patients living with asthma. The minimal value is 15 and the maximum value is 105. The higher score represents a better quality of life	Measured at Baseline and 12- weeks
Secondary	Changes to Asthma Control	Assessed by the Asthma Control Questionnaire. The Asthma Control Questionnaire is a 6-item instrument used to quantify a patient's asthma control. The minimal value is 0 and the maximum value is 36. A higher score represents poorer asthma control.	Measured at Baseline, 12-weeks and continuously for 12-weeks
Secondary	Diagnostic Alignment	Assessed by comparing the breathe application diagnostic output, the patient's historical clinical diagnosis of asthma and the most recent clinical diagnosis.	Measured at 12-weeks
Secondary	Changes to Satisfaction with Care	Assessed by the Satisfaction of Care questionnaire. This questionnaire contains 3 questions used to quantify experience and acceptability of the Breathe ecosystem. The minimal value is 3 and the maximum value is 15. A higher score represents high user satisfaction.	Measured at baseline and at 12-weeks
Secondary	Changes to Treatment Behaviour	Assessed by the Observed Treatment Behaviour Questionnaire. This questionnaire is a 43-item instrument that quantifies a patient's attitude towards their asthma and treatment. The minimum value is 43 and the maximum value is 215. A higher score represents poorer attitude toward asthma and treatment.	Measured at Baseline and 12-weeks
Secondary	Changes to patient's healthcare utilization	Assessed by the number of urgent asthma-related health care visits following an asthma exacerbation.	Measured at Baseline and 12- weeks
Secondary	Maintenance Medication Adherence	Assessed by formal dose counting of maintenance medication done in clinic at study end.	Measured at 12-weeks
Secondary	Rescue Medication Use	Assessed by the number of rescue inhaler uses detected by a peripheral inhaler component.	Measured at 12-weeks
Secondary	Asthma Control	Percentage of time spent across asthma action plan zones of control.	Measured at 12-weeks