NCT03978936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

June 5, 2019

Last Update Submit

January 14, 2026

Conditions

Keywords

Bronchial DiseasesRespiratory Tract DiseasesLung DiseasesObstructive Lung Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

MTM-EAM

EXPERIMENTAL

Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]

Behavioral: Medication Therapy Management (MTM) Video TelehealthcareBehavioral: Electronic Adherence Self-Management (EAM)

EAM only

ACTIVE COMPARATOR

Electronic Adherence Self-Management \[EAM\] only

Behavioral: Electronic Adherence Self-Management (EAM)

Interventions

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

MTM-EAM

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

EAM onlyMTM-EAM

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

University of Florida College of Medicine

Jacksonville, Florida, 32209, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5360, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10029, United States

Location

Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Vermont Lung Center at The University of Vermont

Colchester, Vermont, 05466, United States

Location

Pacific Northwest Airways - VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Bronchial DiseasesRespiratory Tract DiseasesLung DiseasesLung Diseases, Obstructive

Interventions

Medication Therapy Managementmyotubularin

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services Administration

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, parallel, superiority trial with two intervention groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

November 18, 2019

Primary Completion

March 14, 2025

Study Completion

June 30, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations