Monitoring Adherence Using Mobile Technology

NCT02617420 | Completed

• 1 other identifier: 15-0211
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study plans to learn more about how children use their asthma medicines. The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Number of patient participants that rate the devices as easy to use

  Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having children/parents answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.

  3 months

• Number of provider participants that rate the devices as easy to use

  Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having providers answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.

  3 months

Secondary Outcomes (3)

• Number of patients/parents that exhibit behavioral changes with respect to taking asthma medications as a result of information gained from the monitoring devices.

  3 months

• Number of pediatric pulmonary providers that exhibit behavioral changes with respect to prescribing asthma medications as a result of information gained from the monitoring devices.

  3 months

• Correlation of lung function to percent use of controller medications as measured by adherence devices.

  3 months

Study Arms (1)

Intervention

All patients will be enrolled in one arm. These patients will have monitoring devices placed on their asthma controller and rescue medication, with data transmitted both to their smartphones and a dashboard accessed by their primary pediatric pulmonary provider.

Device: Propeller Health Monitoring Device

Interventions

Propeller Health Monitoring Device DEVICE

Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects would be drawn from the list of high risk asthma patients and by pre-clinic chart review done by study investigator.

You may qualify if:

• age 6-17 years and their parents
• either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months
• requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (LABA).
• Patients using metered dose inhaler therapy would be eligible. Patients may also be on leukotriene antagonists,
• Must be made aware that they will have to read and accept to the terms of the User Agreement prior to enrollment in the study. If they do not agree they will not be able to continue participation. The User agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request.

You may not qualify if:

• Primary language other than English or Spanish
• Presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status.
• Patients using diskus therapy.
• Patients only on leukotriene antagonists.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (1)

• Hoch H, Kempe A, Brinton J, Szefler S. Feasibility of medication monitoring sensors in high risk asthmatic children. J Asthma. 2019 Mar;56(3):270-272. doi: 10.1080/02770903.2018.1446979. Epub 2018 Apr 11. No abstract available.

  PMID: 29641374 DERIVED

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

• Stanley Szefler, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09