Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05594654
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-31
First Post:
2022-05-10
Brief Title:
A Digital Respiratory Ecosystem for People Living With Asthma
Sponsor:
Asthma Research Group Windsor-Essex Inc
Organization:
Asthma Research Group Windsor-Essex Inc
Study Overview
Official Title:
A Digital Respiratory Ecosystem for People Living With Asthma Mixed Methods
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 asthmaCOPD 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 78 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 60000 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 patients 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 20 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 20 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 platforms assessment of asthma control and the respective recommendations
While Breathe 20 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 patients 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
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 patients 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 20 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 20 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 platforms assessment of asthma control and the respective recommendations
While Breathe 20 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None