Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04250779
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-01-29
Brief Title:
Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
Sponsor:
Landon Pediatric Foundation
Organization:
Landon Pediatric Foundation
Study Overview
Official Title:
Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
MOMMIASTHMA1
Brief Summary:
Asthma affects over 10 million children in the US and poses a significant health and cost burden Metered dose inhaler MDI is the most common method of treatment Studies show that up to 80 of patients demonstrate incorrect use of MDIs which results in suboptimal medication delivery to the lungs
Asthma control can be followed by symptoms rescue medication usage and measures of airflow obstruction Current options to monitor control include an asthma diary relies on consistent use by the patient pharmacy records of medication dispensing dispensing does not equal usage and peak expiratory flow PEF meters significant variability in technique leading to inconsistent results
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler CapMedic includes a built-in forced expiratory flow in 1 second FEV1 a measure of airflow and PEF meter It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patients effort in performing accurate at-home FEV1PEF test Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary
Asthma control can be followed by symptoms rescue medication usage and measures of airflow obstruction Current options to monitor control include an asthma diary relies on consistent use by the patient pharmacy records of medication dispensing dispensing does not equal usage and peak expiratory flow PEF meters significant variability in technique leading to inconsistent results
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler CapMedic includes a built-in forced expiratory flow in 1 second FEV1 a measure of airflow and PEF meter It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patients effort in performing accurate at-home FEV1PEF test Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary
Detailed Description:
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler CapMedic includes a built-in forced expiratory flow in 1 second FEV1 a measure of airflow and PEF meter It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patients effort in performing accurate at-home FEV1PEF test Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None