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

Early Phase 1

• Conditions: Adherence, Medication; Childhood Asthma; Asthma
• Interventions: Behavioral: Video-based guidance; Device: CapMedic smart inhaler device

• Registration Number: NCT04250779
• Lead Sponsor: Landon Pediatric Foundation

Brief 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.

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 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 Timeline

• Study Start: 2019-07-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Video-based guidance	In this arm, patients are provided with standard-of-care instructions on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned off.
Treatment Group	CapMedic smart inhaler device	In this arm, patients are provided with active guidance from CapMedic device on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned on.

Primary Outcome Measures

Name	Time	Method
MDI use Competence in Clinic	1 day	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
MDI use Competence at home	8 weeks	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

Secondary Outcome Measures

Name	Time	Method
PEF Lung Function in Clinic	1 day	PEF measured using CapMedic device during recruitment. PEF is measured in L/min.
FEV1 Lung Function in Clinic	1 day	FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L.
MDI use Adherence	8 weeks	Regularity of MDI use measured by CapMedic device at home, measured as a % of puffs taken per week compared to prescribed dosage.
FEV1 Lung Function at home	8 weeks	FEV1 measured using CapMedic device at home. FEV1 is measured in L.
PEF Lung Function at home	8 weeks	PEF measured using CapMedic device at home. PEF is measured in L/min.

Trial Locations

Locations (1)

Pediatric Diagnostic Center; 🇺🇸 Ventura, California, United States