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Treatment Phenotypes for Adolescents With Asthma

Primary Purpose

Asthma in Children, Adherence, Treatment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication monitoring
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Childrens Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Qualitative information regarding barriers for medication use
Qualitative data (semistructured interviews with patients regarding barriers to medication use.
Qualitative information regarding barriers for medication use
Qualitative data (focus groups with providers) regarding barriers to medication use.
Qualitative information regarding facilitators for medication use
Qualitative data (semistructured interviews with patients) to determine facilitators to medication use.
Qualitative information regarding facilitators for medication use
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.

Full Information

First Posted
January 10, 2020
Last Updated
March 13, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04228107
Brief Title
Treatment Phenotypes for Adolescents With Asthma
Official Title
Treatment Phenotypes for Adolescents With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Adherence, Treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Medication monitoring
Intervention Description
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 Outcome Measure Information:
Title
Treatment Phenotypes
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Qualitative information regarding barriers for medication use
Description
Qualitative data (semistructured interviews with patients regarding barriers to medication use.
Time Frame
12 months
Title
Qualitative information regarding barriers for medication use
Description
Qualitative data (focus groups with providers) regarding barriers to medication use.
Time Frame
12 months
Title
Qualitative information regarding facilitators for medication use
Description
Qualitative data (semistructured interviews with patients) to determine facilitators to medication use.
Time Frame
12 months
Title
Qualitative information regarding facilitators for medication use
Description
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather EH De Keyser, MD MS
Phone
720-777-4108
Email
heather.dekeyser@childrenscolorado.org
First Name & Middle Initial & Last Name or Official Title & Degree
Karissa Valente
Phone
720-777-8486
Email
Karissa.Valente@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather EH De Keyser, MD MS
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather E De Keyser, MD
Phone
720-777-4108
Email
heather.dekeyser@childrenscolorado.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment Phenotypes for Adolescents With Asthma

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