Treatment Phenotypes for Adolescents With Asthma

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Adherence, Treatment; Asthma in Children

Treatments: Device: Medication monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04228107

19-1861

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Cohort

Experimental group

Description:

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

Treatment:

Device: Medication monitoring