Asthma in Children Clinical Trial
Official title:
Treatment Phenotypes for Adolescents With Asthma
Verified date | April 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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". The investigators will use group based trajectory modeling to evaluate adherence and control phenotypes; In essence, they will evaluate the adherence trajectory of each subject, as well as the control phenotype of each patient, and then use this information to determine into which of the four groups the participant falls. The outcome reported will be the number of subjects in each group. | 12 months | |
Secondary | Qualitative information regarding barriers for medication use | Qualitative data (semistructured interviews with patients regarding barriers to medication use. | 12 months | |
Secondary | Qualitative information regarding barriers for medication use | Qualitative data (focus groups with providers) regarding barriers to medication use. | 12 months | |
Secondary | Qualitative information regarding facilitators for medication use | Qualitative data (semistructured interviews with patients) to determine facilitators to medication use. | 12 months | |
Secondary | Qualitative information regarding facilitators for medication use | Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. | 12 months |
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