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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04228107
Other study ID # 19-1861
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 16, 2020
Est. completion date May 31, 2026

Study information

Verified date April 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date May 31, 2026
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
United States Childrens Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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". 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. 12 months
Secondary Qualitative information regarding barriers for medication use Qualitative data (semistructured interviews with patients regarding barriers to medication use. 12 months
Secondary Qualitative information regarding barriers for medication use Qualitative data (focus groups with providers) regarding barriers to medication use. 12 months
Secondary Qualitative information regarding facilitators for medication use Qualitative data (semistructured interviews with patients) to determine facilitators to medication use. 12 months
Secondary Qualitative information regarding facilitators for medication use Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use. 12 months
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