Medication Adherence With Telehealthcare Medication Therapy Management (MATCH)

Johns Hopkins University

Status: Completed

Conditions: Young Adults; Uncontrolled Asthma

Treatments: Behavioral: Electronic Adherence Self-Management (EAM); Behavioral: Medication Therapy Management (MTM) Video Telehealthcare

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03978936

3R01HL136945-01A1S1 (U.S. NIH Grant/Contract)

1R01HL136945-01A1 (U.S. NIH Grant/Contract)

IRB00197194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

321 participants in 2 patient groups

MTM-EAM

Experimental group

Description:

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

Treatment:

Behavioral: Medication Therapy Management (MTM) Video Telehealthcare

Behavioral: Electronic Adherence Self-Management (EAM)

EAM only

Active Comparator group

Description:

Electronic Adherence Self-Management \[EAM\] only

Treatment:

Behavioral: Electronic Adherence Self-Management (EAM)