MATCH: Medication Adherence With Telehealthcare Medication Therapy Management

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03978936

Collaborator

Nemours Children's Health System (Other), American Lung Association (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

300

Enrollment

Locations

Arms

55.4

Anticipated Duration (Months)

13.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Asthma Young Adults	Behavioral: Medication Therapy Management (MTM) Video Telehealthcare Behavioral: Electronic Adherence Self-Management (EAM)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, parallel, superiority trial with two intervention groupsRandomized, 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 :

Nov 18, 2019

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time (days) to first exacerbation event [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.
Proportion of adherent days as assessed by Propeller sensors [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	University of Arizona	Tucson	Arizona	United States	85724
3	University of California at San Francisco	San Francisco	California	United States	94143
4	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
5	Nemours Children's Specialty Care	Jacksonville	Florida	United States	32207
6	University of Florida College of Medicine	Jacksonville	Florida	United States	32209
7	University of Illinois at Chicago	Chicago	Illinois	United States	60608
8	Northwestern University	Chicago	Illinois	United States	60611
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	University of Chicago Hospitals	Chicago	Illinois	United States	60637
11	St. Vincent Hospital and Health Care Center, Inc.	Indianapolis	Indiana	United States	46260
12	University of Kansas Medical Center	Kansas City	Kansas	United States	66103
13	University of Michigan	Ann Arbor	Michigan	United States	48109-5360
14	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
15	New York University School of Medicine	New York	New York	United States	10016
16	Columbia University Medical Center	New York	New York	United States	10029
17	Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine	New York	New York	United States	10029
18	Duke University Medical Center	Durham	North Carolina	United States	27710
19	Temple University	Philadelphia	Pennsylvania	United States	19140
20	Baylor College of Medicine	Houston	Texas	United States	77030
21	Vermont Lung Center at The University of Vermont	Colchester	Vermont	United States	05466
22	Pacific Northwest Airways - VA Puget Sound Healthcare System	Seattle	Washington	United States	98108

Sponsors and Collaborators

Johns Hopkins University
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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