Treatment Phenotypes for Adolescents With Asthma

Asthma in Children Clinical Trial

Official title:

Treatment Phenotypes for Adolescents With Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04228107
• Other study ID #: 19-1861
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Asthma
• Asthma in Children

Intervention

Device:
• Medication 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

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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