Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364527
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-27
Brief Title:
Use of Aptar Digital Healths Respiratory Disease Management Platform for Asthma
Sponsor:
CoheroHealth
Organization:
CoheroHealth
Study Overview
Official Title:
Use of Aptar Digital Healths Respiratory Disease Management Platform for Asthma A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
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 United Kingdom has a high prevalence of asthma over 12 and some of the worst health outcomes in Europe The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service With the advancement of digital health technology there is the potential to transform patient care and improve outcomes
The Aptar Digital Health respiratory disease management platform a digital therapeutic will be utilized to determine its value and how it supports i asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence ii asthma control through the use of the Asthma Control Questionnaire-5 In addition spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines
The Aptar Digital Health respiratory disease management platform a digital therapeutic will be utilized to determine its value and how it supports i asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence ii asthma control through the use of the Asthma Control Questionnaire-5 In addition spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines
Detailed Description:
This is an open-label single comparative study that will accrue a total of 118 participants and compare pre and post study results Group 1 will consist of 59 participants with a fractioned exhaled nitric oxide 45 ppb and 3 exacerbations year biologic eligible Group 2 will consist of 59 participants with a fractioned exhaled nitric oxide 45 ppb and 3 exacerbations year non-biologic eligible At the baseline visit clinic appointment 1 health care providers will review the participants medical records to determine clinical outcomes in the past year including number of exacerbations medication pharmacy refill percentage and fractioned exhaled nitric oxide score At the baseline visit participants will also complete the Asthma Control Questionnaire-5 and the Mini-Asthma Quality of Life Questionnaire The past year clinical evaluation and Asthma Control Questionnaire-5 and Mini-Asthma Quality of Life Questionnaire will be considered baseline results
Patients will be screened for study appropriateness at the Guys Hospital Severe Asthma Clinic During the initial visit which will be considered the study baseline visit patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline patients will be scheduled for virtual visits at 3-months post-baseline
Patients will then be trained by Guys Hospital team members Aptar Digital Health staff will provide extensive training to the Guys Hospital team prior to the study to ensure the team is fully knowledgeable about the product its features and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform Once participants are trained they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store or Google Play
The BreatheSmart mobile application records stores and transmits usage events to the HeroTracker sensors or via manual user entry to a remote storage system Participants may self-enter their medication schedule either with or without the help of their health care providers Through the BreatheSmart mobile application they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors report and review their adherence and self-reported symptoms and answer validated questionnaires
Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers Health care providers are then able to utilize BreatheSmart Connect a web application to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information Health care providers can view real-time adherence medication list participants within and outside of risk zones depending on adherence rescue medication usage symptoms and triggers Based on the information gleaned from the BreatheSmart Connect platform clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guys Hospital Severe Asthma Clinic
Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion
Patients will be screened for study appropriateness at the Guys Hospital Severe Asthma Clinic During the initial visit which will be considered the study baseline visit patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline patients will be scheduled for virtual visits at 3-months post-baseline
Patients will then be trained by Guys Hospital team members Aptar Digital Health staff will provide extensive training to the Guys Hospital team prior to the study to ensure the team is fully knowledgeable about the product its features and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform Once participants are trained they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store or Google Play
The BreatheSmart mobile application records stores and transmits usage events to the HeroTracker sensors or via manual user entry to a remote storage system Participants may self-enter their medication schedule either with or without the help of their health care providers Through the BreatheSmart mobile application they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors report and review their adherence and self-reported symptoms and answer validated questionnaires
Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers Health care providers are then able to utilize BreatheSmart Connect a web application to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information Health care providers can view real-time adherence medication list participants within and outside of risk zones depending on adherence rescue medication usage symptoms and triggers Based on the information gleaned from the BreatheSmart Connect platform clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guys Hospital Severe Asthma Clinic
Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion
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