NCT04250779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1 asthma

Timeline
Completed

Started Jul 2019

Typical duration for early_phase_1 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 16, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 29, 2020

Last Update Submit

September 13, 2020

Conditions

AsthmaAdherence, MedicationChildhood Asthma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • PEF Lung Function in Clinic

    1 day

  • FEV1 Lung Function in Clinic

    1 day

  • PEF Lung Function at home

    8 weeks

  • FEV1 Lung Function at home

    8 weeks

  • MDI use Adherence

    8 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Treatment Group

ACTIVE COMPARATOR

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

Interventions

CapMedic smart inhaler deviceDEVICE

The CapMedic device provides active coaching to promote correct and regular use of MDI.

Treatment Group
Video-based guidanceBEHAVIORAL

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.

Control Group

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without asthma
  • With developmental disabilities
  • Do not speak English
  • Do not own a Smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Diagnostic Center

Ventura, California, 93003, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35691614DERIVED

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Chris Landon, M.D.

CONTACT

8053401366chris.landon@ventura.org

Emilie Paronyan

CONTACT

8184393664emilieparonyann@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

September 16, 2020

Record last verified: 2020-01

Locations

US(1)