Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH)
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). The primary outcome is the time to first exacerbation event defined as a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, emergency department visit, or hospitalization.
Study phase: N/A
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
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)
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
Primary disease category: Asthma & Lung
Secondary disease categories: Asthma & Lung, Children, Infants & Newborns, Healthy Volunteers
This study is enrolling healthy volunteers.
Sponsor: American Lung Association
Protocol number: 1909998505
Projected enrollment dates: September 2019 to September 2022
Official study title: Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH)
External link(s):
Asthma & Airway Disease Research Center
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT03978936