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Incentives for Adherence in Adolescent Asthma

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ClinicalTrials.gov Identifier: NCT03515499
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE July 6, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03515499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • 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, barriers and facilitators to adequate medication adherence.
  • 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, barriers and facilitators to adequate medication adherence.
  • 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, as well as facilitators of incentives, using semi-structured interviews. The investigators will obtain information on incentives to adequate medication adherence.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incentives for Adherence in Adolescent Asthma
Official Title  ICMJE Incentives for Medication Adherence in Adolescents With Asthma
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Asthma
  • Asthma in Children
Intervention  ICMJE
  • 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.
  • Behavioral: Medication device monitoring and reminders
    Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Medication device monitoring and reminders
  • 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.
    Interventions:
    • Behavioral: Incentives
    • Behavioral: Medication device monitoring and reminders
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Hoch, MD 720-777-4108 heather.hoch@childrenscolorado.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515499
Other Study ID Numbers  ICMJE 18-0089
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heather Hoch, MD Assistant Professor
PRS Account University of Colorado, Denver
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP