Medication Adherence With Telehealthcare Medication Therapy Management

Young Adults Clinical Trial

— MATCH  

Official title:

Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03978936
• Other study ID #: IRB00197194
• Secondary ID: 1R01HL136945-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Uncontrolled Asthma
• Young Adults

Intervention

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
• Electronic Adherence Self-Management (EAM)
Participants will have a sensor which monitors their adherence to medication use

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
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 Illinois at Chicago	Chicago	Illinois
United States	Vermont Lung Center at The University of Vermont	Colchester	Vermont
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Nemours Children's Specialty Care	Jacksonville	Florida
United States	University of Florida College of Medicine	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
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	New York University School of Medicine	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of California at San Francisco	San Francisco	California
United States	Pacific Northwest Airways - VA Puget Sound Healthcare System	Seattle	Washington
United States	University of Arizona	Tucson	Arizona

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months