Back to resultsBreathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propeller Health device + asthma navigator
Sponsored by
About this trial
This is an interventional health services research trial for Asthma
Eligibility Criteria
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.
Sites / Locations
- Childrens Hospital Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Barriers to Adherence of Patient Asthma Inhalers
Measured via questionnaire data obtained every 2 months. Reported at 6 months.
Effectiveness of Communication Between Providers
measured via survey to providers at the end of the intervention
Full Information
NCT ID
NCT03065205
First Posted
August 25, 2016
Last Updated
December 9, 2019
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03065205
Brief Title
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Official Title
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Propeller Health device + asthma navigator
Intervention Description
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 Outcome Measure Information:
Title
Change in Adherence of Use of Patient Asthma Inhalers
Description
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.
Time Frame
Week 1 to Week 24
Secondary Outcome Measure Information:
Title
Degree of Asthma Control
Description
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
Time Frame
6 months
Title
Barriers to Adherence of Patient Asthma Inhalers
Description
Measured via questionnaire data obtained every 2 months. Reported at 6 months.
Time Frame
6 months
Title
Effectiveness of Communication Between Providers
Description
measured via survey to providers at the end of the intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather E Hoch, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
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