Telehealthcare MTM for Asthma

(MATCH Trial)

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses video calls and sensors to help young people with asthma take their medication regularly. It targets those who struggle with sticking to their prescribed treatment, aiming to improve their health by providing support and reminders.

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 data supports the effectiveness of the treatment Electronic Adherence Self-Management (EAM), Inhaled corticosteroid (ICS), Medication Therapy Management (MTM) Video Telehealthcare for asthma?

Research shows that regular use of inhaled corticosteroids (ICS) can improve asthma symptoms and prevent flare-ups. Simplifying the ICS regimen may lead to better adherence, which is crucial for effective asthma management. ^{1 2 3 4 5}

Is the use of inhaled corticosteroids (ICS) generally safe for asthma treatment?

Inhaled corticosteroids (ICS) are generally considered safe for treating asthma, with clinical guidelines supporting their use for long-term symptom control. However, there are ongoing concerns about potential side effects, which are important to discuss with a healthcare provider. ^{6 7 8 9 10}

How is the drug inhaled corticosteroid (ICS) unique for treating asthma?

Inhaled corticosteroids (ICS) are unique for treating asthma because they are the most effective anti-inflammatory drugs available, specifically targeting the inflammation in the airways that causes asthma symptoms. They are administered directly to the lungs through inhalation, which helps reduce systemic side effects compared to oral medications. ^{11 12 13 14 15}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Age-dependent deterioration of peak inspiratory flow with two kinds of dry powder corticosteroid inhalers (Diskus and Turbuhaler) and relationships with asthma control. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to inhaled corticosteroids prescribed once vs twice daily in children with asthma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Early achievement and maintenance of stable asthma control using initially higher-dose inhaled corticosteroids as part of combination therapy: an open-label pilot study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Measuring safety of inhaled corticosteroids in asthma. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Inhaled corticosteroids for asthma: are they all the same? [2009]

8. England pubmed.ncbi.nlm.nih.gov

Inhaled corticosteroids and asthma control in adult-onset asthma: 12-year follow-up study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Systematic review of the evidence regarding potential complications of inhaled corticosteroid use in asthma: collaboration of American College of Chest Physicians, American Academy of Allergy, Asthma, and Immunology, and American College of Allergy, Asthma, and Immunology. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of inhaled corticosteroids in the treatment of persistent asthma. [2022]

11. Thailand pubmed.ncbi.nlm.nih.gov

Evaluation of asthma control by inhaled corticosteroids in general practice in Thailand. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Inhaled Corticosteroids and Endocrine Effects in Childhood. [2021]

13. France pubmed.ncbi.nlm.nih.gov

[Deliberate interruptions and changes of dose of inhaled corticosteroids by asthma patients: "a community pharmacy study"]. [2015]

14. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic characteristics and adrenal suppression with newer inhaled corticosteroids: A comparison of ciclesonide and fluticasone propionate. [2023]

15. Egypt pubmed.ncbi.nlm.nih.gov

Patterns and determinants of compliance with inhaled steroids in adults with asthma. [2018]