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AsthmaEarly Phase 1NCT03615248

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

A Early Phase 1 study testing BreatheSuite in people with Asthma and Asthma in Children, run by Memorial University of Newfoundland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Asthma, Asthma in Children
What is being tested?
BreatheSuite
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Jan 2021to 31 Mar 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Memorial University of Newfoundland

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

Other trials in Canada

About this study

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

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.

Read the detailed description

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:

  1. the dose was given,
  2. the metered dose inhaler was properly shaken,
  3. the metered dose inhaler is properly aligned,
  4. the flow of medication is appropriate, and
  5. 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.

Being tested
BreatheSuite
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BreatheSuiteDevice

    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:

    1. the dose was given,
    2. the metered dose inhaler was properly shaken,
    3. the metered dose inhaler is properly aligned,
    4. the flow of medication is appropriate and
    5. there is no accidental exhalation into the inhaler.
Study groups in NCT03615248
Study groupRoleWhat they receive
Primary Arm -Experimental30 Subjects will be approached in Asthma Clinics at the Janeway Children's Health and Rehabilitation Centre by the research nurse, and if selected to the study, will use the BreatheSuite device for 3-6 months. 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 research nurse or pediatrician without parent or caregiver intervention;
Receives: Device: BreatheSuite

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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:

    1. the dose was given,
    2. the metered dose inhaler was properly shaken,
    3. the metered dose inhaler is properly aligned, and
    4. the flow of medication is appropriate.
    5. 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.

    Measured: 3-6 Months

Secondary outcomes (1)

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

    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

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start1 Jan 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615248
Sponsor's protocol ID
MemorialUN001
Status last verified
Apr 2022
First submitted
18 Jul 2018
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Sickle D, Magzamen S, Truelove S, Morrison T. Remote monitoring of inhaled bronchodilator use and weekly feedback about asthma management: an open-group, short-term pilot study of the impact on asthma control. PLoS One. 2013;8(2):e55335. doi: 10.1371/journal.pone.0055335. Epub 2013 Feb 27.

    PubMed 23460785

  • Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S, Halwani R, Al-Muhsen S. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. 2013 Mar 6;9(1):8. doi: 10.1186/1710-1492-9-8.

    PubMed 23510684

  • Burkhart PV, Rayens MK, Bowman RK. An evaluation of children's metered-dose inhaler technique for asthma medications. Nurs Clin North Am. 2005 Mar;40(1):167-82. doi: 10.1016/j.cnur.2004.08.010.

    PubMed 15733954

  • Sleath B, Ayala GX, Gillette C, Williams D, Davis S, Tudor G, Yeatts K, Washington D. Provider demonstration and assessment of child device technique during pediatric asthma visits. Pediatrics. 2011 Apr;127(4):642-8. doi: 10.1542/peds.2010-1206. Epub 2011 Mar 28.

    PubMed 21444594

  • Ronmark E, Jogi R, Lindqvist A, Haugen T, Meren M, Loit HM, Sairanen U, Sandahl A, Lundback B. Correct use of three powder inhalers: comparison between Diskus, Turbuhaler, and Easyhaler. J Asthma. 2005 Apr;42(3):173-8.

    PubMed 15962873

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BreatheSuite in people with Asthma and Asthma in Children, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Does the given mobile health intervention improve inhaler technique in children aged 10-18? (time frame: 3-6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615248, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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