Clinical trial NCT03978936: Medication Adherence With Telehealthcare Medication Therapy Management
Official title: Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uncontrolled Asthma
Young Adults
Keywords: Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Obstructive Lung Diseases
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Nemours Children's Health System
name: American Lung Association
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, superiority trial with two intervention groups
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Time (days) to first exacerbation event
timeFrame: 12 months
measure: Proportion of adherent days as assessed by Propeller sensors
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Colchester
country: United States
facility: Vermont Lung Center at The University of Vermont
state: Vermont
city: Seattle
country: United States
facility: Pacific Northwest Airways - VA Puget Sound Healthcare System
state: Washington
Study officials:
affiliation: Nemours Children's Specialty Care
name: Kathryn Blake, Pharm.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Robert Wise, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Janet Holbrook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.