Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support

Asthma Clinical Trial

Official title:

Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065205
• Other study ID #: 16-1845
• Status: Completed
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if an asthma navigator is helpful in improving communication between care providers and improving patient adherence to asthma medications after an asthma exacerbation.

Description:

This study will aim to use technology to evaluate the effectiveness of a patient navigator for childhood asthma. The Investigators will place adherence monitoring devices on patient inhalers, and track use of patient asthma medicines. The Investigators will also utilize an asthma navigator who will discuss adherence with families and help to address any barriers to adherence that families identify. Additionally, the navigator will communicate patient specific adherence information to the patient's primary care physician (PCP) and school nurse. The adherence monitor will monitor communications between these providers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age 6-17 years old,

• Admission to Children's Hospital Colorado with an asthma exacerbation between Jan 1 2017 and Dec 31 2017.

Exclusion Criteria:

• Language other than English or Spanish (application for monitoring adherence is only available in these languages)

• Presence of other complex medical problems including:

• Cystic Fibrosis,

• Tracheostomy/ventilator dependence,

• other severe chronic lung disease, and

• significant developmental delays.

• Home schooled or not in school

• Following up with an allergy or pulmonary provider outside the CHCO system after hospital discharge.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Propeller Health device + asthma navigator
The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adherence of Use of Patient Asthma Inhalers	Adherence will be measured via adherence monitoring devices for 6 months per patient. Change in device measured adherence from week 1 to week 24. Measured as change in average number of puffs of controller medication taken/puffs individually prescribed, measured between weeks 1 and 24.	Week 1 to Week 24
Secondary	Degree of Asthma Control	Measured via questionnaire data using Asthma Control Test (ACT) or Childhood Asthma Control Test (cACT) every 2 months. Reported at 6 months. Scores range from 5-25 on the ACT and 0-27 on the cACT. Scores >19 on either test indicate good asthma control	6 months
Secondary	Barriers to Adherence of Patient Asthma Inhalers	Measured via questionnaire data obtained every 2 months. Reported at 6 months.	6 months
Secondary	Effectiveness of Communication Between Providers	measured via survey to providers at the end of the intervention	6 months