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

NCT03615248 | Completed Early Phase 1

• 1 other identifier: MemorialUN001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma in Children

Outcome Measures

Primary Outcomes (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.

  3-6 Months

Secondary Outcomes (1)

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

  3-6 months

Other Outcomes (2)

• To compare patient satisfaction between BreatheSuite and the logbook

  3-6 months

• To assess patient satisfaction with BreatheSuite

  3-6 months

Study Arms (1)

Primary Arm -

EXPERIMENTAL

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

Interventions

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: 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 Arm -

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University of Newfoundland

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

Location

Related Publications (5)

• 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.

  PMID: 23460785 BACKGROUND

• 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.

  PMID: 23510684 BACKGROUND

• 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.

  PMID: 15733954 BACKGROUND

• 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.

  PMID: 21444594 BACKGROUND

• 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.

  PMID: 15962873 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mary Jane Smith, MD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 3, 2018
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)