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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma, Adherence, Medication, Childhood Asthma

Intervention / Treatment
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* Device: CapMedic smart inhaler device
* Behavioral: Video-based guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Research will initially involve collection of data describing the participants' current use of their medication following standard education. Subsequent phases will add audio / haptic coaching to the process of administering medication by MDI, and follow the same participants to determine whether or not there is improvement in technique and adherence to therapy. The device will be used with a placebo inhaler (given AFTER the participant's regular medication is taken by standard techniques), to determine how participants use the device, and to identify the most effective coaching interventions for this age group. This is to ensure that the device does not interfere with delivery of routine asthma controller medications. The data will be used to develop a subsequent, longer term study in which we will evaluate the effect of the coaching device on asthma control, when it is used with the subject's controller medication.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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. | Behavioral: Video-based guidance<br>* 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.<br>|
| Active Comparator: Treatment Group<br>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. | Device: CapMedic smart inhaler device<br>* The CapMedic device provides active coaching to promote correct and regular use of MDI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDI 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 | 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEF Lung Function in Clinic | PEF measured using CapMedic device during recruitment. PEF is measured in L/min. | 1 day | 
| FEV1 Lung Function in Clinic | FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L. | 1 day | 
| PEF Lung Function at home | PEF measured using CapMedic device at home. PEF is measured in L/min. | 8 weeks | 
| FEV1 Lung Function at home | FEV1 measured using CapMedic device at home. FEV1 is measured in L. | 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. | 8 weeks |