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

NCT ID: NCT03065205

Last Updated: 2019-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Single Arm

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.

Group Type EXPERIMENTAL

Propeller Health device + asthma navigator

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather E Hoch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Childrens Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-1845

Identifier Type: -

Identifier Source: org_study_id