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

Primary Purpose

Asthma, Asthma in Children

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
BreatheSuite
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial University of Newfoundland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Arm -

Arm Description

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;

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2018
Last Updated
April 7, 2022
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT03615248
Brief Title
Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma
Official Title
Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma in Children

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Arm -
Arm Type
Experimental
Arm Description
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;
Intervention Type
Device
Intervention Name(s)
BreatheSuite
Intervention Description
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.
Primary Outcome Measure Information:
Title
Does the given mobile health intervention improve inhaler technique in children aged 10-18?
Description
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.
Time Frame
3-6 Months
Secondary Outcome Measure Information:
Title
To compare the Asthma Control Questionnaire scores before and after use of BreathSuite
Description
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
Time Frame
3-6 months
Other Pre-specified Outcome Measures:
Title
To compare patient satisfaction between BreatheSuite and the logbook
Description
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.
Time Frame
3-6 months
Title
To assess patient satisfaction with BreatheSuite
Description
A the end of the study a short Exit Survey will be administered which asks subjects their level of satisfaction with Breathesuite.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jane Smith, MD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23460785
Citation
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.
Results Reference
background
PubMed Identifier
23510684
Citation
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.
Results Reference
background
PubMed Identifier
15733954
Citation
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.
Results Reference
background
PubMed Identifier
21444594
Citation
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.
Results Reference
background
PubMed Identifier
15962873
Citation
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.
Results Reference
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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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