Incentives for Adherence in Adolescent Asthma

Study Overview
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Brief Summary
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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
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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

Official Title
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Incentives for Medication Adherence in Adolescents With Asthma

Conditions
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Asthma, Asthma in Children

Intervention / Treatment
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* Behavioral: Incentives
* Behavioral: Medication device monitoring and reminders


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Behavioral: Medication device monitoring and reminders<br>* Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.<br>|
| Experimental: Treatment arm<br>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. | Behavioral: Incentives<br>* 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.<br>Behavioral: Medication device monitoring and reminders<br>* Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Daily for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 3 months of monitoring | 
| 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. | After 3 months of monitoring | 
| 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. | After 3 months of monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Incentives