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Completed

NCT Number: NCT03615248

Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma

In this trial, the investigators aim to determine if a new mobile health intervention (BreatheSuite) can increase inhaler technique and adherence amongst participants aged 10-18. See the below detailed description for more information.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

About this study

Improper inhaler technique can significantly affect the amount of medication reaching the lungs and patients with the incorrect technique are likely to have poorly controlled asthma and more emergency department visits. Studies have shown that up to 92% of children demonstrate poor inhaler technique. A systematic review of errors in inhaler technique showed that most errors were in coordination, speed or depth of inspiration, and no post inhalation breath-hold.

BreatheSuite (patent pending) is a device and mobile application developed by Mr. Brett Vokey, an engineering student at Memorial University of Newfoundland. BreatheSuite has been recognized by numerous provincial competitions, featured at the Eastern Health Innovation Showcase, and was recently selected as a finalist for the New York Health Innovation Challenge.

This device attaches to metered dose inhalers and it can determine if:

  • the dose was given,
  • the metered dose inhaler was properly shaken,
  • the metered dose inhaler is properly aligned,
  • the flow of medication is appropriate, and
  • there is no accidental exhalation into the inhaler.

All of this information is transmitted to the BreatheSuite mobile application, which is then available to the user. The user will get technique correcting advice via push notifications as well as by accessing the mobile application directly. The healthcare professional can look at the data to determine where more education can be given and tailor treatment to the individual.

Similar to that done of a study by Ronmark et al, inhaler technique scores are computed from 0-100%, with each of the five technique steps mentioned above are given one of three values: 20 (Perfect Score for Technique Step), 10 (partially correct step) or 0 (not correct at all). Thus, the technique scores are varied from 0-100 in increments of 10.

One downfall of many metered dose inhalers is that they do not include a dose indicator. The patient can not know how many doses are remaining. The number of doses in each metered dose inhaler is clearly labelled on the canister. However, if patients are not keeping track in their asthma logbook, or elsewhere, they may not know when their device is empty. This downfall can lead to omitted doses and poor control. BreatheSuite's ability in monitoring doses has the potential to enhance medication adherence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10-18,
  • diagnosis of asthma by the pediatrician,
  • regular access to a smartphone,
  • parental consent,
  • ongoing need for regular use of a medication delivered by metered dose inhaler as deemed by the pediatrician,
  • ability to demonstrate proper technique of metered dose inhaler use in the clinic while supervised by Asthma Nurse or pediatrician without parent or caregiver intervention

Exclusion criteria

  • Children 9 or under.
  • Individuals not using a metered dose inhaler.
  • Individuals without a smartphone.
  • Individuals taking part in another drug/device study at this time
  • Individuals who have finished another drug/device study in the last 30 days

Treatment and study plan

BreatheSuite

Device

BreatheSuite (patent pending) is a device and mobile application developed by Mr. Brett Vokey, an engineering student at Memorial University of Newfoundland. BreatheSuite has been recognized by numerous provincial competitions, featured at the Eastern Health Innovation Showcase, and was recently selected as a finalist for the New York Health Innovation Challenge.

This device attaches to metered dose inhalers and it can determine if:

  • the dose was given,
  • the metered dose inhaler was properly shaken,
  • the metered dose inhaler is properly aligned,
  • the flow of medication is appropriate and
  • there is no accidental exhalation into the inhaler.

Primary outcomes

  1. Does the given mobile health intervention improve inhaler technique in children aged 10-18?

    Time frame: 3-6 Months

    Detailed outcome measures include:

    To compare the metered dose inhaler technique before and after use of BreatheSuite.This device attaches to metered dose inhalers and it can determine if:

    • the dose was given,
    • the metered dose inhaler was properly shaken,
    • the metered dose inhaler is properly aligned, and
    • the flow of medication is appropriate.
    • there is no accidental exhalation into the inhaler.

    Similar to that done of a study by Ronmark et al, inhaler technique scores are computed from 0-100%, with each of the five technique steps mentioned above are given one of three values: 20 (Perfect Score for Technique Step), 10 (partially correct step) or 0 (not correct at all). Thus, the technique scores are varied from 0-100 in increments of 10.

Secondary outcomes

  1. To compare the Asthma Control Questionnaire scores before and after use of BreathSuite

    Time frame: 3-6 months

    Asthma Control Questionnaire is a validated questionnaire which assesses asthma control over the previous week. It will be administered at the beginning of the study and upon study completion 3-6 months later

Other outcomes

  1. To compare patient satisfaction between BreatheSuite and the logbook

    Time frame: 3-6 months

    At the end of the study a short Exit Survey has will be administered which asks subjects about their experience including whether they prefer using Breathesuite to track their inhaler use or an asthma logbook.

  2. To assess patient satisfaction with BreatheSuite

    Time frame: 3-6 months

    A the end of the study a short Exit Survey will be administered which asks subjects their level of satisfaction with Breathesuite.

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Official study title

Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma: A Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2018
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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