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Medication Adherence With Telehealthcare Medication Therapy Management (MATCH)

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ClinicalTrials.gov Identifier: NCT03978936
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Uncontrolled Asthma Young Adults Behavioral: Medication Therapy Management (MTM) Video Telehealthcare Behavioral: Electronic Adherence Self-Management (EAM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, parallel, superiority trial with two intervention groups
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. Time (days) to first exacerbation event [ Time Frame: 12 months ]
    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.

  2. Proportion of adherent days as assessed by Propeller sensors [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 14 through 30 years
  • Speaks English or Spanish
  • Physician diagnosed asthma (without any other co-morbid pulmonary disease)
  • Prescribed ICS treatment for at least 6 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, Xopenex
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978936


Contacts
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Contact: Heather Hazucha, MPH 410-502-0585 hhazuch1@jhu.edu

Locations
Show Show 23 study locations
Sponsors and Collaborators
Johns Hopkins University
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03978936    
Other Study ID Numbers: IRB00197194
1R01HL136945-01A1 ( U.S. NIH Grant/Contract )
3R01HL136945-01A1S1 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Obstructive Lung Diseases
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases