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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Asthma in Children
• Intervention / Treatment: Device: BreatheSuite

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Memorial University of Newfoundland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	3-6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare patient satisfaction between BreatheSuite and the logbook	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.	3-6 months
To assess patient satisfaction with BreatheSuite	A the end of the study a short Exit Survey will be administered which asks subjects their level of satisfaction with Breathesuite.	3-6 months

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland
• Investigators: Principal Investigator: Mary Jane Smith, MD, Memorial University of Newfoundland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MemorialUN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No