Asthma
Conditions
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.
Interventions
DEVICEPropeller 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
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence of Use of Patient Asthma Inhalers | 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
| Measure | Time frame | Description |
|---|---|---|
| Degree of Asthma Control | 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 |
| Barriers to Adherence of Patient Asthma Inhalers | 6 months | Measured via questionnaire data obtained every 2 months. Reported at 6 months. |
| Effectiveness of Communication Between Providers | 6 months | measured via survey to providers at the end of the intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 9.08 years STANDARD_DEVIATION 2.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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.
Time frame: Week 1 to Week 24
Population: Participants who were in the study for the 6 month period and had analyzable study data for at least 16 weeks of monitored time.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm | Change in Adherence of Use of Patient Asthma Inhalers | -0.36 Change in puffs taken/prescribed per wk |
Secondary
Barriers to Adherence of Patient Asthma Inhalers
Measured via questionnaire data obtained every 2 months. Reported at 6 months.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Forgot | 15 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Felt child was better | 3 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Thought child didn't need it | 2 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Afraid inhaler could lead to addiction | 1 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Afraid inhaler could damage child | 1 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Side effects of inhaler | 1 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Inhaler not helping child | 1 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Didn't understand doctor's instructions | 0 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Thought method of application was too complicated | 0 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Child not cooperating with administration | 4 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Inhaler empty | 4 Participants |
| Single Arm | Barriers to Adherence of Patient Asthma Inhalers | Other reasons | 16 Participants |
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
Time frame: 6 months
Population: Total number of participants who responded to the 6 month survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Degree of Asthma Control | Mean ACT score | 20.6 score on a scale | Standard Deviation 5.4 |
| Single Arm | Degree of Asthma Control | Mean cACT score | 23.81 score on a scale | Standard Deviation 3.23 |
Secondary
Effectiveness of Communication Between Providers
measured via survey to providers at the end of the intervention
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Effectiveness of Communication Between Providers | Communication increased due to study | 1 Participants |
| Single Arm | Effectiveness of Communication Between Providers | Communicated with other providers once or twice | 4 Participants |