Asthma affects over 10 million children in the U.S., 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 patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.
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 patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
50
The CapMedic device provides active coaching to promote correct and regular use of MDI.
Patients are shown a video of how to use inhalers correctly and any questions are answered by the clinician. They are also encouraged to use inhalers regularly and correctly at home.
Pediatric Diagnostic Center
Ventura, California, United States
RECRUITINGMDI use Competence in Clinic
Correctness of Inhaler Use measured using CapMedic device during recruitment. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation
Time frame: 1 day
MDI use Competence at home
Correctness of Inhaler Use measured using CapMedic device at home. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation
Time frame: 8 weeks
PEF Lung Function in Clinic
PEF measured using CapMedic device during recruitment. PEF is measured in L/min.
Time frame: 1 day
FEV1 Lung Function in Clinic
FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L.
Time frame: 1 day
PEF Lung Function at home
PEF measured using CapMedic device at home. PEF is measured in L/min.
Time frame: 8 weeks
FEV1 Lung Function at home
FEV1 measured using CapMedic device at home. FEV1 is measured in L.
Time frame: 8 weeks
MDI use Adherence
Regularity of MDI use measured by CapMedic device at home, measured as a % of puffs taken per week compared to prescribed dosage.
Time frame: 8 weeks
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