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This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.
This study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. Participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. The study team will collect data on medication use patterns in a real world setting for 12 months per participant. Additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental | Participants will be enrolled in medication use monitoring. Their medication use patterns will be available to themselves and their guardians via a smartphone application, and to their asthma care providers via a portal. There will be no interventions to change medication use patterns. A portion of them will be asked to participate in a semistructured interview during which they will be asked questions about their perception of their asthma, health beliefs regarding medication use, and what they feel would be the most helpful to get them to take their asthma medicines. Additionally a small group of healthcare providers will be asked to participate in a focus group to collect qualitative data on medication use barriers and facilitators |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication monitoring | Device | This is an observational study of medication use patterns. The propeller health device has reminders for controller medication use and gives feedback regarding medication use to the participant, their guardian and their asthma provider |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Phenotypes | The Investigators will calculate the number of participants that fall into the following treatment phenotypes: "Well controlled-good adherence", "Well controlled-poor adherence", "Poorly controlled-good adherence", "Poorly controlled-poor adherence". We had initially planned to report only these 4 groups, however there was a very clear breakdown into 9 groups-as we needed to consider a moderately controlled group and a moderately adherent group. Therefore the groups are reported as follows: Poor Adhrence, Poor control Poor adherence, moderate control poor adherence, good control Moderate adherence, poor control moderate adherence, moderate control moderate adherence, good control good adherence, poor control good adherence, moderate control good adherence, good control The investigators will use group based trajectory modeling to evaluate adherence and control phenotypes | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Information Regarding Barriers for Medication Use | Qualitative data (semistructured interviews with patients regarding barriers to medication use. | 12 months |
| Qualitative Information Regarding Facilitators for Medication Use |
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For adolescent participants:
Inclusion Criteria:
Exclusion Criteria:
Other significant chronic lung disease (from problem list)
Significant developmental delay
Taking more than 3 asthma related medications
Primary language other than English, Spanish, Catalan, Dutch, French, German or Italian
Healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.
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| Name | Affiliation | Role |
|---|---|---|
| Heather EH De Keyser, MD MS | 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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70 adolescent participants were enrolled for the primary aim. 10 healthcare providers were enrolled to participate in focus groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescents With Medication Monitoring | Participants will be enrolled in medication use monitoring. Their medication use patterns will be available to themselves and their guardians via a smartphone application, and to their asthma care providers via a portal. There will be no interventions to change medication use patterns. |
| FG001 | Healthcare Provider Focus Groups | Healthcare providers will be enrolled in focus groups to discuss medication adherence in teens. Healthcare provider demographics were not collected as part of focus group participation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only adolescent participants with greater than 11 months (47 weeks) of synced data were included in the final analysis.
10 healthcare providers were enrolled for focus group participation, however demographic data was not collected on these providers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents | Teens enrolled for electronic medication monitoring. 43 participants completed at least 11 months of medication monitoring and were included in the final analysis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors. |
| 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 | Treatment Phenotypes | The Investigators will calculate the number of participants that fall into the following treatment phenotypes: "Well controlled-good adherence", "Well controlled-poor adherence", "Poorly controlled-good adherence", "Poorly controlled-poor adherence". We had initially planned to report only these 4 groups, however there was a very clear breakdown into 9 groups-as we needed to consider a moderately controlled group and a moderately adherent group. Therefore the groups are reported as follows: Poor Adhrence, Poor control Poor adherence, moderate control poor adherence, good control Moderate adherence, poor control moderate adherence, moderate control moderate adherence, good control good adherence, poor control good adherence, moderate control good adherence, good control The investigators will use group based trajectory modeling to evaluate adherence and control phenotypes | Posted | Number | Participants | 12 months |
|
n/a-study was observational so adverse events were not recorded.
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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 | Adolescents | Adolescents monitored for medication use | 0 |
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There were a few limitations to this evaluation. First, we were under our recruitment target. This was due to a number of factors, most importantly that most of the primary study recruitment efforts occurred during the early years of the COVID pandemic, which made recruitment challenging. Additionally, though we made every effort to ensure that study sensors remained on the participants medications, we had some participants whose devices stopped syncing at some point during analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather De Keyser MD MSCS | University of Colorado | 720-777-4108 | heather.dekeyser@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 | Sep 22, 2023 | Jun 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2022 | Jul 10, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016903 | Drug Monitoring |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use.
| 12 months |
| Qualitative Information Regarding Facilitators for Medication Use | Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. | 12 months |
| Qualitative Information Regarding Barriers for Medication Use | Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. | 12 months |
| Lost to Follow-up |
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| No controller use data |
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| No medication data collected |
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| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors. | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors. | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors. | Count of Participants | Participants | No |
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| FEV1 Z score | FEV1 Z score was directly obtained from the medical record (i.e. it is calculated based on population level characteristics and is reported as a clinical measure). Z scores of +/- 1.64 are considered within normal limits. Z scores less than -1.64 or greater than +1.64 are considered abnormal. Z scores of 0 represent the population mean. | Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors. | Median | Inter-Quartile Range | Z score |
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Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
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| Secondary | Qualitative Information Regarding Barriers for Medication Use | Qualitative data (semistructured interviews with patients regarding barriers to medication use. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Qualitative Information Regarding Facilitators for Medication Use | Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Qualitative Information Regarding Facilitators for Medication Use | Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Qualitative Information Regarding Barriers for Medication Use | Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. | Posted | Count of Participants | Participants | 12 months |
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