Clinical trial NCT02617420: Monitoring Adherence Using Mobile Technology
Official title: Monitoring Adherence Using Mobile Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of patient participants that rate the devices as easy to use
timeFrame: 3 months
measure: Number of provider participants that rate the devices as easy to use
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients/parents that exhibit behavioral changes with respect to taking asthma medications as a result of information gained from the monitoring devices.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Correlation of lung function to percent use of controller medications as measured by adherence devices.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Stanley Szefler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.