Coach McLungs Intervention for Asthma

Overseen By Thomas Ludden, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Atrium Health

Disqualifiers: Decisional impaired, mentally incompetent

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Coach McLungs, a virtual tool designed to manage asthma more effectively. The researchers aim to evaluate its effectiveness in primary care settings by examining its impact on asthma attacks and the need for emergency care or steroids. The trial compares two groups: one using the Coach McLungs program and one not using it. It seeks children aged 5-17 with persistent asthma who speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative asthma management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Coach McLungs intervention is safe for asthma patients?

Research shows that the Coach McLungs Intervention aims to help children and teens manage asthma more effectively. Studies have found that collaborative decision-making between doctors and families can improve asthma outcomes. However, specific safety information for the Coach McLungs Intervention itself is not available.

The trial is marked as "Not Applicable" for its phase, indicating that the intervention is low-risk. It primarily involves decision-making support and education, rather than a new drug or treatment. This suggests it is safe and free of major safety concerns. Nonetheless, consulting a doctor for specific questions or concerns is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coach McLungs Intervention because it offers a novel approach to managing asthma that goes beyond the typical medication regimen. Unlike standard treatments like inhaled corticosteroids and bronchodilators, which primarily focus on reducing inflammation and opening airways, Coach McLungs is an educational and behavioral intervention. This approach empowers patients by teaching them how to better manage their condition through lifestyle changes and improved self-monitoring. By focusing on patient education and engagement, Coach McLungs has the potential to reduce asthma attacks and improve overall quality of life for individuals with asthma.

What evidence suggests that the Coach McLungs Intervention is effective for asthma?

Research has shown that the Coach McLungs program can improve asthma in children by encouraging doctors and patients to make decisions together. This approach, known as shared decision making, has been linked to better asthma control in previous studies. In this trial, some participants will use the Coach McLungs online tool, which makes learning about asthma more engaging for kids and their caregivers and provides personalized tips for more effective asthma management. Studies have found that these strategies can lead to fewer emergency room visits and hospital stays due to asthma attacks. ^{2 6 7 8 9}

Who Is on the Research Team?

Hazel Tapp, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for children and teens aged 5-17 with mild to severe persistent asthma who can communicate in English or Spanish. It's not suitable for those who have decision-making impairments or are mentally incompetent.

Inclusion Criteria

I have been diagnosed with persistent asthma.

Exclusion Criteria

I am able to make my own health decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Coach McLungsSM SDM intervention into primary care practices using a stepped wedge randomized control study design

18 months

Ongoing virtual integration and training sessions

Follow-up

Participants are monitored for changes in emergency department visits, hospitalizations, and oral steroid use as surrogate measures for asthma outcomes

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Coach McLungs Intervention

Trial Overview The study tests the Coach McLungsSM intervention, a virtual tool designed to help manage asthma through education and clinical support. The effectiveness will be measured by looking at emergency visits, hospital stays, and oral steroid use due to asthma.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Coach McLungs not yet implemented in practice

Group II: Intervention Active Control 1 Intervention

Coach McLungs Implemented in Practice

Coach McLungs Intervention is already approved in United States for the following indications:

Approved in United States as Coach McLungs for:

• Asthma management
• Uncontrolled asthma in pediatric patients

Who Is Running the Clinical Trial?

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Asthma self-management education significantly improves outcomes for individuals with chronic asthma, yet in 2003, only a small percentage of asthma patients received formal education, highlighting a gap in necessary knowledge for effective self-management.

The analysis of the 2003 National Health Interview Survey revealed that asthma education varied widely among different demographic groups, indicating that many individuals, especially youths and adults, lack essential education to manage their asthma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma self-management education among youths and adults--United States, 2003. [2008]

The COACH program, a nurse-driven initiative for asthma care, significantly reduced the likelihood of emergency department visits and readmissions within 30 days after hospital discharge for children with asthma, with an odds ratio of 0.44.

However, there was no significant difference in the overall rate of hospital service utilization within 12 months between participants in the COACH program and those who did not participate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does participation in the community outreach for asthma care and healthy lifestyles (COACH) program alter subsequent use of hospital services for children discharged with asthma? Pinto, JM., Navallo, LJ., Petrova, A.[2021]

A controlled study involving asthma training courses for children showed significant improvements in asthma management, including reduced hospital visits and better self-assessment skills, after a 6-month training program that included family doctors.

The study highlighted that ongoing support from family physicians after the initial training further enhanced confidence and coping strategies for managing asthma, indicating that structured training combined with follow-up care is crucial for effective asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Outcome of structured asthma education in childhood and adolescence]. Szczepanski, R., Gebert, N., Hümmelink, R., et al.[2009]

The Asthma Clinical Research Network and the Childhood Asthma Research and Education Network have conducted numerous clinical trials that significantly influence asthma treatment guidelines, helping to refine existing medications and establish models for evaluating side effects and risks.

These studies have also validated methods for assessing asthma control and identified patient characteristics that predict responses to treatment, although challenges remain in integrating new therapies and personalized medicine into community practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline-defining asthma clinical trials of the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network and Childhood Asthma Research and Education Network. Denlinger, LC., Sorkness, CA., Chinchilli, VM., et al.[2018]

A coaching program for children with asthma from low socioeconomic backgrounds did not significantly reduce healthcare utilization or medication purchases over a one-year follow-up, despite showing a trend towards shorter hospital stays.

Participants in the intervention group reported subjective improvements in asthma control, indicating potential benefits in quality of life, even though objective measures of healthcare use did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a coaching program on asthma control and health care utilization in children with asthma. Horwitz, D., Kestenbom, I., Goldbart, A., et al.[2021]

A team of healthcare professionals focused on improving asthma management by evaluating current practices and developing guidelines, which involved surveying primary care physicians and specialists to understand their methods.

The pilot of a patient outcomes survey tool showed it was effective for tracking asthma patient outcomes, leading to the creation of educational materials for both patients and providers to enhance asthma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice improvement: management of the patient with chronic asthma. Weiss, M.[2019]

The Written Action Plan is an effective tool for asthma management, helping patients adjust their treatment based on symptoms and peak expiratory flow measurements, although its implementation is not consistent among patients and healthcare providers.

To enhance the effectiveness of Written Action Plans, it is crucial to incorporate patient-centered therapeutic education, which encourages patients to take ownership of their plans and ensures that these plans are personalized and meaningful to their lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of written action plans in the management of asthma]. Ouksel, H., Pineau, A.[2021]

The Inner-City Asthma Intervention (ICAI) program successfully implemented a collaboration between a master's level social worker and a physician to address asthma in inner-city children, demonstrating effective management of a common chronic disease.

Key elements for the program's success included addressing administrative challenges, patient recruitment, ongoing education for the team, and community outreach, providing a model for future social worker-physician partnerships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Inner-City Asthma Intervention asthma counselor program: a collaborative model between physician and social worker to help empower families. Rosen, CM., Rodriguez, L.[2019]

A novel nurse telephone coaching intervention was tested in a randomized, controlled trial to improve asthma self-management for parents of children aged 5 to 12 with persistent asthma.

Despite existing guidelines, maintenance asthma care remains inadequate, highlighting the need for effective support systems like this coaching intervention to enhance care and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone coaching intervention to improve asthma self-management behaviors. Swerczek, LM., Banister, C., Bloomberg, GR., et al.[2022]

A comprehensive inpatient asthma education program at Children's Hospital Boston significantly improved education for parents of hospitalized asthma patients and increased the completion rates of individualized asthma action plans (AAPs).

The program, based on NHLBI/NAEPP guidelines, utilized various teaching strategies and emphasized self-management, leading to better compliance and understanding of asthma management among families before discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient asthma education program. McCarty, K., Rogers, J.[2022]

A study involving 107 African American parents of children with persistent asthma showed that using wellness coaches for a parent-focused stress management intervention was both feasible and acceptable, with 79% of sessions completed.

The wellness coaches effectively delivered the intervention, covering 92%-95% of the intended content, suggesting that this approach could be beneficial for improving asthma outcomes and may be applicable to other pediatric health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness coaches in intervention delivery: pediatric asthma as an example. Streisand, R., Waters, D., Fousheé, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05059210

Primary Care Implementation and Evaluation of Coach ... Previous studies, including a PCORI-funded dissemination study, have shown that SDM is associated with improved outcomes for asthma patients in primary care.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36333727/

Implementation of Coach McLungs SM into primary care ... The goal of this study is to evaluate the implementation of the Coach McLungs SM intervention into primary care.

3. annfammed.org annfammed.org/content/23/Supplement_1/7578

Baseline Demographic Characteristics of Asthma Patients ... Improved asthma outcomes are associated with effective communication strategies between patients and providers. Coach McLungs is a shared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10549668/

Coaching for Asthma to Achieve Better Health Outcomes ... Coach McLungsSM is an interactive web-based application that engages pediatric patients and their caregivers in a personally tailored experience and collects ...

5. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-022-02030-1

Implementation of Coach McLungs SM into primary care using ... Effectiveness: Patient health outcomes data of acute care visits for asthma exacerbations will be analyzed for patients who have a diagnosis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636750/

Implementation of Coach McLungsSM into primary care ... Results of asthma outcomes for each practice will be presented to the practice at the 12-month post kick-off visit along with comparison ...

7. ebm.bmj.com ebm.bmj.com/content/29/Suppl_1/A101.1

216 Is shared decision-making taking place? Process and ... CML aims to improve outcomes for pediatric patients with asthma, yielding summary reports for both the patient and provider so the two parties together can ...

8. withpower.com withpower.com/trial/phase-asthma-6-2022-89619

Coach McLungs Intervention for Asthma However, specific safety data for Coach McLungs Intervention itself is not provided in the available studies. Show more. How does the Coach McLungs ...

9. researchgate.net researchgate.net/publication/365129814_Implementation_of_Coach_McLungs_into_primary_care_using_a_cluster_randomized_stepped_wedge_trial_design

(PDF) Implementation of Coach McLungsSM into primary ... National Vital Statistics System (NVSS) data were used to estimate asthma deaths. ... safety event outcomes (near miss, precursor, and serious safety events).