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Clinical Trials/NCT03515499
NCT03515499CompletedNot Applicable

Incentives for Medication Adherence in Adolescents With Asthma

University of Colorado, Denver2 sites in 1 country52 target enrollmentStarted: July 6, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
2
Primary Endpoint
Change in adherence rates

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Change in adherence rates

Time Frame: Daily for 12 weeks

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 Outcomes

  • Changes in Qualitative outcomes - Barriers(After 3 months of monitoring)
  • Changes in Qualitative outcomes - Incentives(After 3 months of monitoring)
  • Changes in Qualitative outcomes - Facilitators(After 3 months of monitoring)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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