Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uncontrolled Asthma
- Sponsor
- Johns Hopkins University
- Enrollment
- 321
- Locations
- 21
- Primary Endpoint
- Proportion of adherent days as assessed by Propeller sensors
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an at-risk population of Adolescents and Young Adults (AYA) with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.
Detailed Description
The study evaluates a Medication Therapy Management (MTM) video telehealthcare intervention to address poor medication adherence. In addition, it employs a novel method to track and provide feedback to participants on adherence by using Propeller Sensors. 300 adolescents and young adults will be randomized to Medication Therapy Management (MTM) video telehealthcare plus electronic adherence self-management \[MTM EAM\] or electronic adherence self-management alone (EAM). Due to the hierarchal design of the trial, two primary outcomes to be tested in a sequential manner are specified, adherence and time to first asthma exacerbation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 12 through 35 years
- •Speaks English or Spanish
- •Physician diagnosed asthma (without any other co-morbid pulmonary disease)
- •Prescribed ICS treatment for at least 3 months prior to screening
- •Adherence to Refills and Medication Scale (ARMS) 7-item questionnaire score of \>8 (low or moderate adherence)
- •Current use of albuterol metered dose inhaler (MDI) for rescue: ProAir, Ventolin, albuterol sulfate (from Prasco or Teva)
- •Uncontrolled asthma:
- •Symptomatic asthma defined as 3 of the following in the past 4 weeks:
- •Daytime symptoms of asthma more than twice per week
- •Any night awakening due to asthma
Exclusion Criteria
- •Use of an investigational treatment in the previous 30 days.
- •Previous enrollment in MATCH Structured Interviews ( Aim 1)
- •Currently enrolled in an intervention trial
- •Currently uses an ICS not compatible with the Propeller sensor
- •Inability to comply with study procedures, including:
- •Inability or unwillingness to provide informed consent (or assent in the case of a minor).
- •Inability to perform study measurements.
- •inability to be contacted by phone via calls and /or text messaging
- •Not willing to have video chat
- •Any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study
Outcomes
Primary Outcomes
Proportion of adherent days as assessed by Propeller sensors
Time Frame: 12 months
Adherence will be measured using data collected from Propeller sensors. Adherence for each day is calculated as the number of inhalations taken divided by the expected number of doses. A day will be defined as adherent if the participant completes 80% or more of the prescribed inhalations. The primary outcome will be the proportion of adherent days over the course of follow-up, i.e. from the randomization visit to the 1-year visit.
Time (days) to first exacerbation event
Time Frame: 12 months
Time to first asthma exacerbation is the time to first exacerbation event defined as a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, or asthma-specific emergency department visit with treatment with systemic corticosteroids, or asthma-specific hospitalization, or death (all cause and asthma exacerbation). 104. These data will be collected by self-report in the "My Asthma" bi-weekly assessment questionnaire, and verified by the study site coordinator with the participant's provider.