Medication Adherence With Telehealthcare Medication Therapy Management
NCT ID: NCT03978936
Last Updated: 2026-01-15
Study Results
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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COMPLETED
NA
321 participants
INTERVENTIONAL
2019-11-18
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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MTM-EAM
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
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
Electronic Adherence Self-Management (EAM)
Participants will have a sensor which monitors their adherence to medication use
EAM only
Electronic Adherence Self-Management \[EAM\] only
Electronic Adherence Self-Management (EAM)
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
Electronic Adherence Self-Management (EAM)
Participants will have a sensor which monitors their adherence to medication use
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
35 Years
ALL
No
Sponsors
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Nemours Children's Health System
OTHER
American Lung Association
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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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
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
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
New York University School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Vermont Lung Center at The University of Vermont
Colchester, Vermont, United States
Pacific Northwest Airways - VA Puget Sound Healthcare System
Seattle, Washington, United States
Countries
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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.
Other Identifiers
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