Uncontrolled Asthma, Young Adults
Conditions
Keywords
Asthma, Adolescents, Young adults, Controller, Medication Therapy Management, Digital monitoring, Clinical trial
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) (also known as Digital Adherence Monitoring \[DAM\]). 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.
Interventions
BEHAVIORALMedication 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
BEHAVIORALElectronic Adherence Self-Management (EAM)
Participants will have a sensor which monitors their adherence to medication use
Sponsors
Johns Hopkins University
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized, parallel, superiority trial with two intervention groups
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ICS Inhaler Adherent Days | Up to 12 months | Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization. |
| Percent Cumulative Incidence Severe Exacerbation | Up to 12 months | Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathryn Blake, Pharm.D
Nemours Children's Specialty Care
PRINCIPAL_INVESTIGATORRobert Wise, MD
Johns Hopkins School of Medicine
PRINCIPAL_INVESTIGATORJanet Holbrook, PhD
Johns Hopkins Bloomberg School of Public Health
Participant flow
Pre-assignment details
375 participants enrolled into the study. 54 declined to participate. 321 participants were randomized to MTM-EAM (n=166) or EAM (n=155). 162 randomized into MTM-EAM contributed adherence outcomes data and 164 contributed to the efficacy outcomes. 149 randomized into EAM contributed adherence outcomes and 155 to the efficacy outcomes.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 23 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Participants with controller inhalations prescribed per day 1 inhalation | 36 Participants |
| Participants with controller inhalations prescribed per day 2 inhalations | 79 Participants |
| Participants with controller inhalations prescribed per day 4 inhalations | 170 Participants |
| Participants with controller inhalations prescribed per day Greater than 4 inhalations | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black | 39 Participants |
| Race/Ethnicity, Customized More than one race | 3 Participants |
| Race/Ethnicity, Customized Other single races | 1 Participants |
| Race/Ethnicity, Customized Unknown | 14 Participants |
| Race/Ethnicity, Customized White | 104 Participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 155 |
| other Total, other adverse events | 83 / 166 | 77 / 155 |
| serious Total, serious adverse events | 6 / 166 | 14 / 155 |
Outcome results
None listed