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OpenTrials
Completed

NCT Number: NCT03065205

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

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.

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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

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Adherence of Use of Patient Asthma Inhalers

    Time frame: Week 1 to Week 24

    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.

Secondary outcomes

  1. Degree of Asthma Control

    Time frame: 6 months

    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

  2. Barriers to Adherence of Patient Asthma Inhalers

    Time frame: 6 months

    Measured via questionnaire data obtained every 2 months. Reported at 6 months.

  3. Effectiveness of Communication Between Providers

    Time frame: 6 months

    measured via survey to providers at the end of the intervention

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Dec 27, 2019

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.

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