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

Asthma Clinical Trial

— MOMMIASTHMA1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250779
• Other study ID #: MOMMIASTHMA1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2020
• Source: Landon Pediatric Foundation
• Contact: Chris Landon, M.D.
• Phone: 8053401366
• Email: chris.landon[@]ventura.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Asthma
• Childhood Asthma

Intervention

Device:
• CapMedic smart inhaler device
The CapMedic device provides active coaching to promote correct and regular use of MDI.

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.

Locations

Country	Name	City	State
United States	Pediatric Diagnostic Center	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
Landon Pediatric Foundation	Cognita Labs LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PEF Lung Function in Clinic	PEF measured using CapMedic device during recruitment. PEF is measured in L/min.	1 day
Secondary	FEV1 Lung Function in Clinic	FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L.	1 day
Secondary	PEF Lung Function at home	PEF measured using CapMedic device at home. PEF is measured in L/min.	8 weeks
Secondary	FEV1 Lung Function at home	FEV1 measured using CapMedic device at home. FEV1 is measured in L.	8 weeks
Secondary	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