Treatment Phenotypes for Adolescents With Asthma

NCT ID: NCT04228107

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2024-07-14

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.

Conditions

Asthma in Children; Adherence, Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Cohort

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

Group Type: EXPERIMENTAL

Medication monitoring

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather EH De Keyser, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Childrens Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-1861

Identifier Type: -

Identifier Source: org_study_id