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

2700 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the implementation of the Coach McLungsSM shared decision making (SDM) intervention into primary care across a large healthcare system. Coach McLungsSM is a virtual evidence-based asthma intervention with built-in asthma education and clinical decision support. All asthma patients aged 5-17 who attend these practices will be assessed for uncontrolled asthma. Asthma exacerbations attributed to emergency department visits, hospitalizations, and oral steroid use, will be evaluated to serve as surrogate measures for patient-centered asthma outcomes.

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 data supports the effectiveness of the Coach McLungs treatment for asthma?

The Coach McLungs treatment, similar to the COACH program, may help reduce emergency room visits and hospital readmissions shortly after discharge for children with asthma. Additionally, using wellness coaches in asthma interventions has been found to be feasible and well-received, suggesting potential benefits in managing asthma. ^{1 2 3 4 5}

Is Coach McLungs Intervention safe for humans?

The available research on wellness coaches in asthma interventions suggests that using wellness coaches is feasible and acceptable, with high satisfaction reported by participants. However, specific safety data for Coach McLungs Intervention itself is not provided in the available studies. ^{2 5 6 7 8}

How does the Coach McLungs treatment for asthma differ from other treatments?

Coach McLungs is unique because it uses wellness coaches to help manage parental stress, which can improve asthma outcomes in children. This approach focuses on stress management rather than direct medical treatment, making it different from traditional asthma therapies that primarily involve medication. ^{2 5 9 10 11}

Research Team

Hazel Tapp, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 speak English or Spanish.

I have been diagnosed with persistent asthma.

Exclusion Criteria

I am able to make my own health decisions.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

The effect of a coaching program on asthma control and health care utilization in children with asthma. [2021]

3. England 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? [2021]

4. France pubmed.ncbi.nlm.nih.gov

[The role of written action plans in the management of asthma]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Wellness coaches in intervention delivery: pediatric asthma as an example. [2022]

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

Inpatient asthma education program. [2022]

7. United States 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. [2018]

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

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

9. United States 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. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Outcome of structured asthma education in childhood and adolescence]. [2009]

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

A telephone coaching intervention to improve asthma self-management behaviors. [2022]