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Medication Adherence With Telehealthcare Medication Therapy Management

Not Applicable
Completed
Conditions
Young Adults
Uncontrolled Asthma
Registration Number
NCT03978936
Lead Sponsor
Johns Hopkins University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
321
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
  • Rescue inhaler use for symptoms more than twice per week
  • Any activity limitation due to asthma; OR
  • Asthma Control Test score ≤19
  • Has iPhone or Android smart phone with Short Message Service (SMS)
  • Has access to reliable WiFi service and a device with capability for telemedicine study visits
  • Ability to understand and willingness to sign consent documents
  • Evidence of Propeller sensor connection in the 4-week run-in period
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Proportion of adherent days as assessed by Propeller sensors12 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 event12 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (21)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of Arizona

🇺🇸

Tucson, Arizona, United States

University of California at San Francisco

🇺🇸

San Francisco, California, United States

National Jewish Medical and Research Center

🇺🇸

Denver, Colorado, United States

Nemours Children's Specialty Care

🇺🇸

Jacksonville, Florida, United States

University of Florida College of Medicine

🇺🇸

Jacksonville, Florida, United States

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

University of Chicago Hospitals

🇺🇸

Chicago, Illinois, United States

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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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