Back to resultsIncentives for Adherence in Adolescent Asthma
Primary Purpose
Asthma, Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentives
Medication device monitoring and reminders
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring Adherence, Incentives
Eligibility Criteria
Inclusion Criteria:
- physician diagnosed asthma
- on at least one inhaled controller medication
Exclusion Criteria:
- language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
- other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.
Sites / Locations
- Childrens Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Treatment arm
Arm Description
The control arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use.
The treatment arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Additionally, they will be paid up to $1 per day for perfect medication adherence.
Outcomes
Primary Outcome Measures
Change in adherence rates
This Outcome will measure the difference in adherence at the end of the study period between the 2 groups as measured by the adherence devices (calculated as percent adherence per week over the 12 week study period).
Secondary Outcome Measures
Changes in Qualitative outcomes - Barriers
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as barriers of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding barriers to medication adherence
Changes in Qualitative outcomes - Facilitators
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as facilitators of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding facilitators to adequate medication adherence.
Changes in Qualitative outcomes - Incentives
Qualitatively assessed feelings regarding incentives
Qualitative methodology will be used to evaluate patient feelings towards the incentive program.The investigators will obtain information on incentives to adequate medication adherence.
Full Information
NCT ID
NCT03515499
First Posted
February 5, 2018
Last Updated
June 9, 2020
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03515499
Brief Title
Incentives for Adherence in Adolescent Asthma
Official Title
Incentives for Medication Adherence in Adolescents With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)
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
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.
Detailed Description
Two groups will be enrolled. The control group will have mediation monitoring sensors placed on their controller inhalers. The treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma in Children
Keywords
Adherence, Incentives
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use.
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
The treatment arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Additionally, they will be paid up to $1 per day for perfect medication adherence.
Intervention Type
Behavioral
Intervention Name(s)
Incentives
Intervention Description
Subjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups.
Intervention Type
Behavioral
Intervention Name(s)
Medication device monitoring and reminders
Intervention Description
Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.
Primary Outcome Measure Information:
Title
Change in adherence rates
Description
This Outcome will measure the difference in adherence at the end of the study period between the 2 groups as measured by the adherence devices (calculated as percent adherence per week over the 12 week study period).
Time Frame
Daily for 12 weeks
Secondary Outcome Measure Information:
Title
Changes in Qualitative outcomes - Barriers
Description
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as barriers of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding barriers to medication adherence
Time Frame
After 3 months of monitoring
Title
Changes in Qualitative outcomes - Facilitators
Description
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as facilitators of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding facilitators to adequate medication adherence.
Time Frame
After 3 months of monitoring
Title
Changes in Qualitative outcomes - Incentives
Description
Qualitatively assessed feelings regarding incentives
Qualitative methodology will be used to evaluate patient feelings towards the incentive program.The investigators will obtain information on incentives to adequate medication adherence.
Time Frame
After 3 months of monitoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
physician diagnosed asthma
on at least one inhaled controller medication
Exclusion Criteria:
language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Hoch, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers
Learn more about this trial
Incentives for Adherence in Adolescent Asthma
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