A Digital Respiratory Ecosystem for People Living With Asthma

NCT05594654 | Unknown

• 1 other identifier: ARGI-001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Patient Engagement

  Number of unique days patient used the Breathe app

  Measured at 12-weeks

• Component Engagement

  Assess by how often patients are using the different components of the breathe app.

  Measured at 12-weeks

• Technical Issues

  Assess the number of technical issues reported.

  Measured at 12-weeks

Secondary Outcomes (12)

• Changes in Patient's Inhaler Technique

  Measured at continuously over 12- weeks; at baseline and at 12-weeks

• Changes in the quality of home spirometry

  Measured continuously for 12-weeks and at 12-weeks

• Medication Adherence

  Measured at 12-weeks

• Changes to asthma-related quality of life

  Measured at Baseline and 12- weeks

• Changes to Asthma Control

  Measured at Baseline, 12-weeks and continuously for 12-weeks

Interventions

Smart Phone Application OTHER

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.

Also known as: Breathe Application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty adults with a clinical diagnosis of asthma will be enrolled into this study.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asthma Research Group Windsor-Essex Inc: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Asthma Research Group Windsor Essex County Inc

Windsor, Ontario, N8W5V7, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: October 26, 2022
• Study Start: September 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)