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OpenTrials
Completed

NCT Number: NCT04228107

Treatment Phenotypes for Adolescents With Asthma

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

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Key information

Age range

12 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Treatment Phenotypes

    Time frame: 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".

    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

Secondary outcomes

  1. Qualitative Information Regarding Barriers for Medication Use

    Time frame: 12 months

    Qualitative data (semistructured interviews with patients regarding barriers to medication use.

  2. Qualitative Information Regarding Facilitators for Medication Use

    Time frame: 12 months

    Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use.

  3. Qualitative Information Regarding Facilitators for Medication Use

    Time frame: 12 months

    Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.

  4. Qualitative Information Regarding Barriers for Medication Use

    Time frame: 12 months

    Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2020
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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