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

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ClinicalTrials.gov Identifier: NCT03615248
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Jane Smith, Memorial University of Newfoundland

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Asthma in Children Device: BreatheSuite Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma: A Pilot Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Primary Arm -

30 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;

Device: BreatheSuite

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.




Primary Outcome Measures :
  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:

    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.



Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03615248


Contacts
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Contact: Mary Jane Smith, MD 709-777-4017 MaryJane.Smith@easternhealth.ca

Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
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Principal Investigator: Mary Jane Smith, MD Memorial University of Newfoundland

Publications:
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Responsible Party: Mary Jane Smith, Assistant Professor of Pediatrics, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03615248     History of Changes
Other Study ID Numbers: MemorialUN001
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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