Monitoring Adherence Using Mobile Technology

Asthma Clinical Trial

Official title:

Monitoring Adherence Using Mobile Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617420
• Other study ID #: 15-0211
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: September 14, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Propeller Health Monitoring Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of patients/parents that exhibit behavioral changes with respect to taking asthma medications as a result of information gained from the monitoring devices.	How many parents/patients of high risk asthmatic children change behavior regarding how they administer their medications as a result of information that they gained from the devices regarding their adherence to their treatment regimen, gained via phone surveys at 1.5 and 3 months after using the devices. Patients are surveyed if children are greater than 12 years old. Parents are surveyed if children are 6-12 years old.	3 months	No
Secondary	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.	Number of healthcare providers (physicians, nurse practitioners and physician assistants) that feel that their decision-making is affected regarding medication regimens for asthma based on information that they receive on patient adherence from the devices based on survey data gathered at study entry and 3 months after initiation of the devices will be measured.	3 months	No
Secondary	Correlation of lung function to percent use of controller medications as measured by adherence devices.	Evaluate correlation of markers of lung function (spirometry, fractional exhaled nitric oxide (FeNO), with percent adherence as measured by the monitoring devices.	3 months	No