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Clinical Trials/NCT02617420
NCT02617420
Completed
Not Applicable

Monitoring Adherence Using Mobile Technology

University of Colorado, Denver0 sites25 target enrollmentDecember 2015
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Colorado, Denver
Enrollment
25
Primary Endpoint
Number of patient participants that rate the devices as easy to use
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 3 months

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.

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

Time Frame: 3 months

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.

Secondary Outcomes

  • 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)

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