Medication Adherence With Telehealthcare Medication Therapy Management

NCT ID: NCT03978936

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Uncontrolled Asthma Young Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel, superiority trial with two intervention groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MTM-EAM

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

Group Type EXPERIMENTAL

Medication Therapy Management (MTM) Video Telehealthcare

Intervention Type 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)

Intervention Type BEHAVIORAL

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

EAM only

Electronic Adherence Self-Management \[EAM\] only

Group Type ACTIVE_COMPARATOR

Electronic Adherence Self-Management (EAM)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Electronic Adherence Self-Management (EAM)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nemours Children's Health System

OTHER

Sponsor Role collaborator

American Lung Association

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Blake, Pharm.D

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Specialty Care

Robert Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Janet Holbrook, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

University of California at San Francisco

San Francisco, California, United States

Site Status

National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

Nemours Children's Specialty Care

Jacksonville, Florida, United States

Site Status

University of Florida College of Medicine

Jacksonville, Florida, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

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

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Vermont Lung Center at The University of Vermont

Colchester, Vermont, United States

Site Status

Pacific Northwest Airways - VA Puget Sound Healthcare System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33105234 (View on PubMed)

Other Identifiers

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1R01HL136945-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R01HL136945-01A1S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00197194

Identifier Type: -

Identifier Source: org_study_id

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