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

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ClinicalTrials.gov Identifier: NCT04250779
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Cognita Labs LLC
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Asthma Adherence, Medication Childhood Asthma Device: CapMedic smart inhaler device Behavioral: Video-based guidance Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Supportive Care
Official Title: Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

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.




Primary Outcome Measures :
  1. MDI use Competence in Clinic [ Time Frame: 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

  2. MDI use Competence at home [ Time Frame: 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 :
  1. PEF Lung Function in Clinic [ Time Frame: 1 day ]
    PEF measured using CapMedic device during recruitment. PEF is measured in L/min.

  2. FEV1 Lung Function in Clinic [ Time Frame: 1 day ]
    FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L.

  3. PEF Lung Function at home [ Time Frame: 8 weeks ]
    PEF measured using CapMedic device at home. PEF is measured in L/min.

  4. FEV1 Lung Function at home [ Time Frame: 8 weeks ]
    FEV1 measured using CapMedic device at home. FEV1 is measured in L.

  5. MDI use Adherence [ Time Frame: 8 weeks ]
    Regularity of MDI use measured by CapMedic device at home, measured as a % of puffs taken per week compared to prescribed dosage.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250779


Contacts
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Contact: Chris Landon, M.D. 8053401366 chris.landon@ventura.org
Contact: Emilie Paronyan 8184393664 emilieparonyann@gmail.com

Locations
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United States, California
Pediatric Diagnostic Center Recruiting
Ventura, California, United States, 93003
Contact: Chris Landon, MD    805-641-4490    chris.landon@ventura.org   
Principal Investigator: Chris Landon, MD         
Sponsors and Collaborators
Landon Pediatric Foundation
Cognita Labs LLC
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Responsible Party: Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT04250779    
Other Study ID Numbers: MOMMIASTHMA1
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases