Treatment Phenotypes for Adolescents With Asthma

NCT04228107 | Completed Results FDA Device

• 1 other identifier: 19-1861
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma in Children; Adherence, Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Qualitative Information Regarding Barriers for Medication Use

  12 months

• Qualitative Information Regarding Facilitators for Medication Use

  12 months

• Qualitative Information Regarding Facilitators for Medication Use

  12 months

• Qualitative Information Regarding Barriers for Medication Use

  12 months

Study Arms (1)

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

Device: Medication monitoring

Interventions

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

Cohort

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Drug Monitoring

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

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.

Results Point of Contact

• Title: Heather De Keyser MD MSCS
• Organization: University of Colorado

heather.dekeyser@childrenscolorado.org

720-777-4108

Study Officials

• Heather EH De Keyser, MD MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: November 16, 2020
• Primary Completion: July 14, 2024
• Study Completion: July 14, 2024
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)