Telehealthcare MTM for Asthma

(MATCH Trial)

No longer recruiting at 21 trial locations

Overseen By Heather Hazucha, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Inhaled corticosteroids

Disqualifiers: Investigational treatment, Intervention trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telehealth (online healthcare) and video support help young people with asthma adhere better to their inhaler routine. Participants will use either an electronic self-management tool alone or in combination with video healthcare support to enhance adherence to their inhaled corticosteroid (ICS) treatment. The trial targets individuals aged 12 to 35 with poorly controlled asthma, who often experience symptoms such as frequent asthma attacks or nighttime awakenings, and already use an emergency inhaler. Participants must have a smartphone and reliable internet access to join the study. As an unphased trial, this study offers a unique opportunity to explore innovative asthma management tools and potentially improve health routines.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be using an inhaled corticosteroid (ICS) and a specific type of rescue inhaler to participate.

What prior data suggests that these methods are safe for adolescents and young adults with asthma?

Research has shown that inhaled corticosteroids (ICS) are safe and effective for treating asthma. These medications are widely used and have a strong safety record when used as directed. Most people experience few side effects, which are usually mild, such as a sore throat or hoarse voice.

Studies have found that telemedicine, including the Medication Therapy Management Video Telehealthcare, can improve asthma management by enhancing adherence to medication plans. This method has not introduced any new safety issues. It uses digital tools to track and remind patients about their medication.

Overall, both ICS treatment and telemedicine tools have proven safe. They help manage asthma more effectively without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to managing asthma through telehealth. The trial combines Medication Therapy Management (MTM) with Electronic Adherence Self-Management (EAM), introducing a more personalized and convenient way for patients to manage their condition. Unlike traditional asthma treatments that primarily rely on in-person visits and manual adherence tracking, this method leverages video telehealth to deliver therapy and digital tools to monitor medication adherence. By integrating technology, this approach aims to enhance patient engagement and improve outcomes, potentially setting a new standard for asthma care.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that telemedicine can significantly aid in managing asthma. Studies have found that telemedicine makes it easier for individuals to control asthma symptoms, improves quality of life, and enhances adherence to treatment plans. For young people with asthma, telemedicine proves especially useful in managing their condition and tracking symptoms. This trial will compare two approaches: one group will use Electronic Adherence Self-Management (EAM) only, while another group will use Medication Therapy Management Video Telehealthcare plus EAM (MTM-EAM). These telehealth services can help teenagers and young adults adhere more consistently to their inhaled corticosteroid (ICS) treatments, potentially leading to better asthma control. ^{4 6 7 8 9}

Who Is on the Research Team?

Kathryn Blake, PharmD

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

Are You a Good Fit for This Trial?

This trial is for young adults aged 12-35 with uncontrolled asthma and poor medication adherence. Participants must have an Asthma Control Test score ≤19 or experience significant symptoms, use a compatible inhaler, speak English or Spanish, and be able to engage in telehealthcare.

Inclusion Criteria

I am between 12 and 35 years old.

Ability to understand and willingness to sign consent documents

My asthma limits my activities or my Asthma Control Test score is 19 or less.

Exclusion Criteria

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

You have taken a new, unapproved treatment in the last 30 days.

Any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management or Electronic Adherence Self-Management alone

12 months

Bi-weekly assessments (virtual)

Follow-up

Participants are monitored for adherence and asthma exacerbations using Propeller sensors and bi-weekly assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Adherence Self-Management (EAM)
• Inhaled corticosteroid (ICS)
• Medication Therapy Management (MTM) Video Telehealthcare

Trial Overview The MATCH study tests if Telehealthcare Medication Therapy Management (MTM) via video calls and Electronic Adherence Self-Management (EAM) can improve medication adherence in adolescents and young adults with poorly controlled asthma.

How Is the Trial Designed?

Group I: MTM-EAM Experimental Treatment 2 Interventions

Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]

Group II: EAM only Active Control 1 Intervention

Electronic Adherence Self-Management \[EAM\] only

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Nemours Children's Health System

Collaborator

Trials

11

Recruited

17,400+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 232 children with asthma, those prescribed once-daily inhaled corticosteroids (ICS) showed significantly better adherence (66.8% of prescribed days covered) compared to those on a twice-daily regimen (57.9%).

Children on once-daily ICS had a 7.2% higher mean adherence and were more likely to achieve at least 75% adherence, suggesting that simplifying the dosing schedule may improve medication compliance in pediatric asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to inhaled corticosteroids prescribed once vs twice daily in children with asthma. Drouin, O., Smyrnova, A., Bétinjané, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9985125/

Efficacy of Telemedicine for the Management of Asthma The use of telemedicine positively affects asthma management by improving symptom control, patients' quality of life, and adherence to the treatment program.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293541/

Impact of Telemedicine on Asthma Control and Quality of Life ... In pediatric asthma, telemedicine offers the possibility to reinforce self-management, monitor symptoms remotely and improve adherence to ...

3. explorationpub.com explorationpub.com/Journals/eaa/Article/100974

Telemedicine and remote monitoring in asthma care Telemedicine technology, pushed by the COVID-19 pandemic, has improved asthma management, notably treatment adherence.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.24623

Telehealth delivery of adherence and medication ... The CASI trajectories suggest that interventions are most effective in improving asthma control in the initial three visits and less frequent ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03414177

NCT03414177 | Telehealth Enhanced Asthma Management An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807679/

Using Telemedicine to Care for the Asthma Patient - PMC In this review, best practices for starting a telemedicine asthma service with patients at home, distant clinic sites, and various other locations,

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405314/

Asthma management in the digital age - PMC Ever-improving digital tools for asthma assessment and treatment are key components of telemedicine platforms for asthma management.

8. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/respcare.12923

Leveraging Telemedicine and Smartphones to Deliver ... Models of SBTM for children with asthma include medication management, directly observed therapy, care coordination, and education. Results ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2213219821002336

Digital Health Technology in Asthma: A Comprehensive ... Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment.