Adherence, Treatment, Asthma in Children
Conditions
Brief summary
This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.
Detailed description
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.
Interventions
DEVICEMedication monitoring
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
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
12 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
For adolescent participants: Inclusion Criteria: * Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available
Exclusion criteria
* Other significant chronic lung disease (from problem list) * Cystic fibrosis * Chronic respiratory failure * Tracheostomy status * Intersititial lung disease * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Phenotypes | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Information Regarding Barriers for Medication Use | 12 months | Qualitative data (semistructured interviews with patients regarding barriers to medication use. |
| Qualitative Information Regarding Facilitators for Medication Use | 12 months | Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use. |
Countries
United States
Participant flow
Recruitment details
70 adolescent participants were enrolled for the primary aim. 10 healthcare providers were enrolled to participate in focus groups.
Participants by arm
| Arm | Count |
|---|---|
| Adolescents Teens enrolled for electronic medication monitoring. 43 participants completed at least 11 months of medication monitoring and were included in the final analysis | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 0 |
| Overall Study | No controller use data | 1 | 0 |
| Overall Study | No medication data collected | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 0 |
Baseline characteristics
| Characteristic | Adolescents |
|---|---|
| Age, Continuous | 13.8 years STANDARD_DEVIATION 1.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| FEV1 Z score | 0.18 Z score |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adolescents | Treatment Phenotypes | Poor adherence, good control | 7 Participants |
| Adolescents | Treatment Phenotypes | poor adherence, poor control | 2 Participants |
| Adolescents | Treatment Phenotypes | Moderate adherence, good control | 10 Participants |
| Adolescents | Treatment Phenotypes | moderate adherence, poor control | 5 Participants |
| Adolescents | Treatment Phenotypes | high adherence, good control | 16 Participants |
| Adolescents | Treatment Phenotypes | high adherence, poor control | 3 Participants |
Secondary
Qualitative Information Regarding Barriers for Medication Use
Qualitative data (semistructured interviews with patients regarding barriers to medication use.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents | Qualitative Information Regarding Barriers for Medication Use | Theme: poor routine | 8 Participants |
| Adolescents | Qualitative Information Regarding Barriers for Medication Use | Theme: forget | 3 Participants |
Secondary
Qualitative Information Regarding Barriers for Medication Use
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents | Qualitative Information Regarding Barriers for Medication Use | Theme: lack of parental involvement or parenting challenges | 5 Participants |
| Adolescents | Qualitative Information Regarding Barriers for Medication Use | Theme: insurance/cost barriers | 5 Participants |
| Adolescents | Qualitative Information Regarding Barriers for Medication Use | Theme: lack of adolescent understanding or prioritization | 7 Participants |
Secondary
Qualitative Information Regarding Facilitators for Medication Use
Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents | Qualitative Information Regarding Facilitators for Medication Use | Theme: habit | 7 Participants |
| Adolescents | Qualitative Information Regarding Facilitators for Medication Use | Theme: parental reminders | 8 Participants |
| Adolescents | Qualitative Information Regarding Facilitators for Medication Use | Theme: good routine | 12 Participants |
Secondary
Qualitative Information Regarding Facilitators for Medication Use
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescents | Qualitative Information Regarding Facilitators for Medication Use | Theme: buy in from patient/family | 5 Participants |
| Adolescents | Qualitative Information Regarding Facilitators for Medication Use | Theme: tailored approach | 7 Participants |