Medication Adherence With Telehealthcare Medication Therapy Management (MATCH)

Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Young Adults; Uncontrolled Asthma
• Intervention / Treatment: Behavioral: Medication Therapy Management (MTM) Video Telehealthcare; Behavioral: Electronic Adherence Self-Management (EAM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Hazucha, MPH; Phone Number: 410-502-0585; Email: hhazuch1@jhu.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Medical and Research Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Specialty Care
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60608
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospitals
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5360
      • University of Michigan
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • New York, New York, United States, 10029
      • Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
    • New York, New York, United States, 10029
      • Columbia University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Vermont
    • Colchester, Vermont, United States, 05466
      • Vermont Lung Center at The University of Vermont
  • Washington
    • Seattle, Washington, United States, 98108
      • Pacific Northwest Airways - VA Puget Sound Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTM-EAM; Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM]	Behavioral: Medication Therapy Management (MTM) Video Telehealthcare; MTM is an individualized approach to "optimize medication use for improved patient outcomes" and is designed to "empower patients to take an active role in managing patients' medications" thus, providing a favorable strategy for addressing adherence issues. Five core elements define MTM: complete medication therapy review (CMR), creation of a personal medication list (PML), development of a medication action plan (MAP), intervention and/or referral for drug therapy problems, and documentation and follow-up; Behavioral: Electronic Adherence Self-Management (EAM); Participants will have a sensor which monitors their adherence to medication use
Active Comparator: EAM only; Electronic Adherence Self-Management [EAM] only	Behavioral: Electronic Adherence Self-Management (EAM); Participants will have a sensor which monitors their adherence to medication use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (days) to first exacerbation event	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.	12 months
Proportion of adherent days as assessed by Propeller sensors	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.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); American Lung Association; Nemours Children's Health System
• Investigators: Principal Investigator: Kathryn Blake, Pharm.D, Nemours Children's Specialty Care; Principal Investigator: Robert Wise, MD, Johns Hopkins School of Medicine; Principal Investigator: Janet Holbrook, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Blake KV. Telemedicine and adherence monitoring in children with asthma. Curr Opin Pulm Med. 2021 Jan;27(1):37-44. doi: 10.1097/MCP.0000000000000739.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bronchial Diseases; Respiratory Tract Diseases; Obstructive Lung Diseases; Lung Diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: IRB00197194; 1R01HL136945-01A1 (U.S. NIH Grant/Contract); 3R01HL136945-01A1S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No