Incentives for Adherence in Adolescent Asthma

Incentives for Medication Adherence in Adolescents With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Asthma in Children
• Intervention / Treatment: Behavioral: Medication device monitoring and reminders; Behavioral: Incentives

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Heather Hoch, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Adherence; Incentives
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 18-0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• 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