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NCT Number: NCT03515499

Incentives for Adherence in Adolescent 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.

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Key information

Conditions

Asthma Asthma in Children Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Incentives

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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

  1. Changes in Qualitative outcomes - Barriers

    Time frame: After 3 months of monitoring

    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

  2. Changes in Qualitative outcomes - Facilitators

    Time frame: After 3 months of monitoring

    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.

  3. Changes in Qualitative outcomes - Incentives

    Time frame: After 3 months of monitoring

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Incentives for Medication Adherence in Adolescents With Asthma

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 3, 2018
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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