Treatment Phenotypes for Adolescents With Asthma

Not Applicable

Active, not recruiting

• Conditions: Adherence, Treatment; Asthma in Children
• Interventions: Device: Medication monitoring

• Registration Number: NCT04228107
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Study Start: 2020-11-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Medication monitoring	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

Primary Outcome Measures

Name	Time	Method
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". 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.

Secondary Outcome Measures

Name	Time	Method
Qualitative information regarding facilitators for medication use	12 months	Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Qualitative information regarding barriers for medication use	12 months	Qualitative data (focus groups with providers) regarding barriers to medication use.

Trial Locations

Locations (1)

Childrens Hospital Colorado; 🇺🇸 Aurora, Colorado, United States