Monitoring Adherence Using Mobile Technology

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propeller Health Monitoring Device

Device

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.

Time frame: 3 months

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.
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.

Time frame: 3 months

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

Time frame: 3 months

Evaluate correlation of markers of lung function (spirometry, fractional exhaled nitric oxide (FeNO), with percent adherence as measured by the monitoring devices.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Dec 1, 2015
Registry last updated: Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed