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Completed

NCT Number: NCT03978936

Medication Adherence With Telehealthcare Medication Therapy Management

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.

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Key information

Conditions

Uncontrolled Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Young Adults

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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) (also known as Digital Adherence Monitoring [DAM]). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication Therapy Management (MTM) Video Telehealthcare

Behavioral

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

Electronic Adherence Self-Management (EAM)

Behavioral

Participants will have a sensor which monitors their adherence to medication use

Primary outcomes

  1. Proportion of ICS Inhaler Adherent Days

    Time frame: Up to 12 months

    Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%.

    The time frame of 12 months includes a run-in period prior to randomization.

  2. Percent Cumulative Incidence Severe Exacerbation

    Time frame: Up to 12 months

    Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Lung Association
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Nemours Children's Health System

Registry information

Official study title

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

Acronym: MATCH

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2019
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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