Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence (MOMMIASTHMA1)

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.

Study Overview

• Status: Unknown
• Conditions: Asthma; Adherence, Medication; Childhood Asthma
• Intervention / Treatment: Behavioral: Video-based guidance; Device: CapMedic smart inhaler device

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chris Landon, M.D.; Phone Number: 8053401366; Email: chris.landon@ventura.org
• Study Contact Backup: Name: Emilie Paronyan; Phone Number: 8184393664; Email: emilieparonyann@gmail.com

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Recruiting
      • Pediatric Diagnostic Center
      • Contact: Chris Landon, MD; Phone Number: 805-641-4490; Email: chris.landon@ventura.org
      • Principal Investigator: Chris Landon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; 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; 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.
Active Comparator: Treatment Group; 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; The CapMedic device provides active coaching to promote correct and regular use of MDI.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Landon Pediatric Foundation
• Collaborators: Cognita Labs LLC

Publications and helpful links

General Publications

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MOMMIASTHMA1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No