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

NCT ID: NCT03615248

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-03-31

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.

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.

Conditions

Asthma; Asthma in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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;

Group Type: EXPERIMENTAL

BreatheSuite

Intervention Type: 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:

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Mary Jane Smith

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Jane Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 23460785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23510684 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15733954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21444594 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15962873 (View on PubMed)

Other Identifiers

MemorialUN001

Identifier Type: -

Identifier Source: org_study_id