Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
NCT ID: NCT04250779
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2019-07-01
2021-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
CapMedic smart inhaler device
The CapMedic device provides active coaching to promote correct and regular use of MDI.
Interventions
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CapMedic smart inhaler device
The CapMedic device provides active coaching to promote correct and regular use of MDI.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* With developmental disabilities
* Do not speak English
* Do not own a Smartphone
8 Years
ALL
No
Sponsors
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Cognita Labs LLC
INDUSTRY
Landon Pediatric Foundation
OTHER
Responsible Party
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Locations
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Pediatric Diagnostic Center
Ventura, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MOMMIASTHMA1
Identifier Type: -
Identifier Source: org_study_id
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