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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

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.

Condition or disease Intervention/treatment Phase
Asthma Asthma in Children Behavioral: Incentives Behavioral: Medication device monitoring and reminders Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Incentives for Medication Adherence in Adolescents With Asthma
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515499


Contacts
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Contact: Heather Hoch, MD 720-777-4108 heather.hoch@childrenscolorado.org

Locations
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United States, Colorado
Childrens Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Heather E Hoch, MD    720-777-4108    heather.hoch@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Heather Hoch, MD Assistant Professor

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03515499     History of Changes
Other Study ID Numbers: 18-0089
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

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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
Keywords provided by University of Colorado, Denver:
Adherence
Incentives
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases