Uncontrolled AsthmaMATCHNCT03978936
Medication Adherence With Telehealthcare Medication Therapy Management
A study testing Medication Therapy Management (MTM) Video Telehealthcare and Electronic Adherence Self-Management (EAM) in people with Uncontrolled Asthma and Young Adults, run by Johns Hopkins University at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Uncontrolled Asthma, Young Adults
- What is being tested?
- Medication Therapy Management (MTM) Video Telehealthcare and Electronic Adherence Self-Management (EAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 21 sitesUnited States
- Study dates
- 18 Nov 2019to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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 locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109-5360
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Illinois at Chicago
Chicago, Illinois, 60608
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Hospitals
Chicago, Illinois, 60637
Vermont Lung Center at The University of Vermont
Colchester, Vermont, 05466
National Jewish Medical and Research Center
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
University of Florida College of Medicine
Jacksonville, Florida, 32209
University of Kansas Medical Center
Kansas City, Kansas, 66103
Children's Mercy Hospital
Kansas City, Missouri, 64108
New York University School of Medicine
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10029
Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
New York, New York, 10029
Temple University
Philadelphia, Pennsylvania, 19140
University of California at San Francisco
San Francisco, California, 94143
Pacific Northwest Airways - VA Puget Sound Healthcare System
Seattle, Washington, 98108
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
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.
Read the 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.
- Conditions
- Uncontrolled Asthma, Young Adults
- Being tested
- Medication Therapy Management (MTM) Video Telehealthcare, Electronic Adherence Self-Management (EAM)
- Keywords
- Asthma, Adolescents, Young adults, Controller, Medication Therapy Management, Digital monitoring, Clinical trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Therapy Management (MTM) Video TelehealthcareBehavioural
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
Electronic Adherence Self-Management (EAM)Behavioural
Participants will have a sensor which monitors their adherence to medication use
| Study group | Role | What they receive |
|---|---|---|
| MTM-EAM | Experimental | Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] Receives: Behavioral: Medication Therapy Management (MTM) Video Telehealthcare; Behavioral: Electronic Adherence Self-Management (EAM) |
| EAM only | Active comparator | Electronic Adherence Self-Management [EAM] only Receives: Behavioral: Electronic Adherence Self-Management (EAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ICS Inhaler Adherent Days
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.
Measured: Up to 12 months
Percent Cumulative Incidence Severe Exacerbation
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start18 Nov 2019
- Primary completion14 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, superiority trial with two intervention groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Nemours Children's Health System, American Lung Association, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Blake, Pharm.D, Principal investigator, Nemours Children's Specialty CareRobert Wise, MD, Principal investigator, Johns Hopkins School of MedicineJanet Holbrook, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978936
- Sponsor's protocol ID
- IRB00197194
- Other IDs
- 1R01HL136945-01A1, 3R01HL136945-01A1S1
- Acronym
- MATCH
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2019
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33105234
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
- ClinicalTrials.gov ID
- NCT03978936
- Acronym / sponsor ID
- MATCH / IRB00197194
- Conditions
- Uncontrolled Asthma, Young Adults
- Keywords
- Asthma, Adolescents, Young adults, Controller, Medication Therapy Management, Digital monitoring, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Nemours Children's Health System, American Lung Association, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel, superiority trial with two intervention groups
| Arm | Type | Receives |
|---|---|---|
| MTM-EAM | Experimental | Behavioral: Medication Therapy Management (MTM) Video Telehealthcare, Behavioral: Electronic Adherence Self-Management (EAM)Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] |
| EAM only | Active comparator | Behavioral: Electronic Adherence Self-Management (EAM)Electronic Adherence Self-Management [EAM] only |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Therapy Management (MTM) Video TelehealthcareMTM 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 | Behavioural | MTM-EAM |
| Electronic Adherence Self-Management (EAM)Participants will have a sensor which monitors their adherence to medication use | Behavioural | EAM only, MTM-EAM |
Primary outcome
Proportion of ICS Inhaler Adherent Days
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33105234Blake KV. Telemedicine and adherence monitoring in children with asthma. Curr Opin Pulm Med. 2021 Jan;27(1):37-44. doi: 10.1097/MCP.0000000000000739.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Blake, Pharm.D principal investigator
Nemours Children's Specialty Care
Robert Wise, MD principal investigator
Johns Hopkins School of Medicine
Janet Holbrook, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Therapy Management (MTM) Video Telehealthcare and Electronic Adherence Self-Management (EAM) in people with Uncontrolled Asthma and Young Adults, run by Johns Hopkins University at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ICS Inhaler Adherent Days (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.