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Medication Adherence With Telehealthcare Medication Therapy Management (MATCH)

Primary Purpose

Uncontrolled Asthma, Young Adults

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Therapy Management (MTM) Video Telehealthcare
Electronic Adherence Self-Management (EAM)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Uncontrolled Asthma focused on measuring Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of ArizonaRecruiting
  • University of California at San FranciscoRecruiting
  • National Jewish Medical and Research CenterRecruiting
  • Nemours Children's Specialty CareRecruiting
  • University of Florida College of Medicine
  • University of Illinois at ChicagoRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • University of Chicago Hospitals
  • St. Vincent Hospital and Health Care Center, Inc.
  • University of Kansas Medical CenterRecruiting
  • University of MichiganRecruiting
  • Children's Mercy HospitalRecruiting
  • New York University School of Medicine
  • Columbia University Medical CenterRecruiting
  • Mount Sinai National Jewish Health Respiratory Institute; Icahn School of MedicineRecruiting
  • Duke University Medical CenterRecruiting
  • Temple UniversityRecruiting
  • Baylor College of MedicineRecruiting
  • Vermont Lung Center at The University of VermontRecruiting
  • Pacific Northwest Airways - VA Puget Sound Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MTM-EAM

EAM only

Arm Description

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

Electronic Adherence Self-Management [EAM] only

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2019
Last Updated
June 8, 2023
Sponsor
Johns Hopkins University
Collaborators
Nemours Children's Health System, American Lung Association, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03978936
Brief Title
Medication Adherence With Telehealthcare Medication Therapy Management
Acronym
MATCH
Official Title
Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Nemours Children's Health System, American Lung Association, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Asthma, Young Adults
Keywords
Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel, superiority trial with two intervention groups
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MTM-EAM
Arm Type
Experimental
Arm Description
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM]
Arm Title
EAM only
Arm Type
Active Comparator
Arm Description
Electronic Adherence Self-Management [EAM] only
Intervention Type
Behavioral
Intervention Name(s)
Medication Therapy Management (MTM) Video Telehealthcare
Intervention Description
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
Intervention Name(s)
Electronic Adherence Self-Management (EAM)
Intervention Description
Participants will have a sensor which monitors their adherence to medication use
Primary Outcome Measure Information:
Title
Time (days) to first exacerbation event
Description
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.
Time Frame
12 months
Title
Proportion of adherent days as assessed by Propeller sensors
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Hazucha, MPH
Phone
410-502-0585
Email
hhazuch1@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Blake, Pharm.D
Organizational Affiliation
Nemours Children's Specialty Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Wise, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Holbrook, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Rich
Phone
205-638-5134
Email
rrich3@uab.edu
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Schunk
Email
rschunk@arizona.edu
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Christenson, MD
Phone
415-476-0735
Email
stephanie.christenson@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Devin Roberts
Phone
628-233-1233
Email
devin.roberts@ucsf.edu
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juno Pak
Phone
303-398-1443
Email
PakJ@NJHealth.org
Facility Name
Nemours Children's Specialty Care
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Littlefield
Phone
904-697-3092
Email
Michelle.Littlefield@nemours.org
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Owens
Email
Leslie.Owens@nemours.org
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debby Cogley
Phone
312-996-9083
Email
dcogley@uic.edu
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Hixon
Phone
312-926-0975
Email
j-franzen@northwestern.edu
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Fu
Phone
312-942-6352
Email
jun_fu@rush.edu
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Dizon
Phone
847-912-3471
Email
sdizon@medicine.bsd.uchicago.edu
Facility Name
St. Vincent Hospital and Health Care Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurin Brown
Email
lbrown37@kumc.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Nelson
Phone
734-358-7127
Email
belindan@med.umich.edu
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jana Lomonte
Phone
816-302-6308
Email
jblomonte@cmh.edu
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Terminated
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarnjot Saroya
Phone
212-305-0251
Email
tks2127@cumc.columbia.edu
Facility Name
Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ani Cotarlan
Phone
917-583-0037
Email
ani.cotarlan@mountsinai.org
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlin Foy
Phone
919-479-0861
Email
kaitlin.jones@duke.edu
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arwa Mukhtar
Email
Arwa.Mukhtar@tuhs.temple.edu
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Bertrand
Phone
713-798-2681
Email
laura.bertrand@bcm.tmc.edu
Facility Name
Vermont Lung Center at The University of Vermont
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05466
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Horton
Phone
802-847-9803
Email
maya.horton@uvmhealth.org
Facility Name
Pacific Northwest Airways - VA Puget Sound Healthcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Moss
Email
Brianna.Moss@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33105234
Citation
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.
Results Reference
derived

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Medication Adherence With Telehealthcare Medication Therapy Management

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