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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Barriers to Adherence of Patient Asthma Inhalers |
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Inclusion Criteria:
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:
Home schooled or not in school
Following up with an allergy or pulmonary provider outside the CHCO system after hospital discharge.
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| Name | Affiliation | Role |
|---|---|---|
| Heather E Hoch, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who were in the study for the 6 month period and had analyzable study data for at least 16 weeks of monitored time. | Posted | Median | Inter-Quartile Range | Change in puffs taken/prescribed per wk | Week 1 to Week 24 |
|
1 year
Study staff received notifications on patients admitted to the ED or hospital and reviewed them for any connection to the device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Hoch MD | University of Colorado | 720-777-4108 | heather.hoch@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2017 | Nov 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Measured via questionnaire data obtained every 2 months. Reported at 6 months. |
| 6 months |
| Effectiveness of Communication Between Providers | measured via survey to providers at the end of the intervention | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
| 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 | Total number of participants who responded to the 6 month survey. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
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| Secondary | Barriers to Adherence of Patient Asthma Inhalers | Measured via questionnaire data obtained every 2 months. Reported at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Effectiveness of Communication Between Providers | measured via survey to providers at the end of the intervention | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Title | Measurements |
|---|---|
|
| Afraid inhaler could lead to addiction |
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| Afraid inhaler could damage child |
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| Side effects of inhaler |
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| Inhaler not helping child |
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| Didn't understand doctor's instructions |
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| Thought method of application was too complicated |
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| Child not cooperating with administration |
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| Inhaler empty |
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| Other reasons |
|