Young Adults Clinical Trial
— MATCHOfficial title:
Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
Verified date | April 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), Nemours Children's Health System |
United States,
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 |
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