Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Landon Pediatric Foundation
Updated on 16 February 2024
asthma
metered dose inhaler
peak expiratory flow
obstruction
fits
forced expiratory flow

Summary

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.

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 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.

Details
Condition Noncompliance with medication regimen, Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma, Childhood Asthma
Age 8years - 100years
Treatment CapMedic smart inhaler device, Video-based guidance
Clinical Study IdentifierNCT04250779
SponsorLandon Pediatric Foundation
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Asthma
Regular user of MDI
Asthma Control Test (ACT) scores between 15 and 25
FEV1 between 60-80% of predicted (persistent mild-moderate)
Disease severity in the range mild-moderate
Access to a Smartphone and internet during the entire duration of the study
Cognitively able to utilize the device and express interest in participating

Exclusion Criteria

Patients without asthma
With developmental disabilities
Do not speak English
Do not own a Smartphone
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