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

NCT03065205 | Completed Results FDA Device

• 1 other identifier: 16-1845
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Degree of Asthma Control

  6 months

• Barriers to Adherence of Patient Asthma Inhalers

  6 months

• Effectiveness of Communication Between Providers

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.

Device: Propeller Health device + asthma navigator

Interventions

Propeller Health device + asthma navigator DEVICE

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

Single Arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-17 years old,
• Admission to Children's Hospital Colorado with an asthma exacerbation between Jan 1 2017 and Dec 31 2017.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Heather Hoch MD
• Organization: University of Colorado

heather.hoch@childrenscolorado.org

720-777-4108

Study Officials

• Heather E Hoch, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: February 27, 2017
• Study Start: February 16, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)