Incentives for Adherence in Adolescent Asthma

Asthma Clinical Trial

Official title:

Incentives for Medication Adherence in Adolescents With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515499
• Other study ID #: 18-0089
• Status: Completed
• Phase: N/A
• Start date: July 6, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: June 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.
• Medication device monitoring and reminders
Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.

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	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	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
Secondary	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
Secondary	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