What side effects are associated with this type of intervention?

The most common treatments for Asthma-COPD Overlap Syndrome (ACOS) include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA), often used in combination. Known side effects of ICS include oral thrush, hoarseness, and an increased risk of pneumonia. LABAs can cause tremors, palpitations, and muscle cramps, while LAMAs may lead to dry mouth, constipation, and urinary retention. Combination therapies can potentially amplify these side effects, but they are generally well-tolerated when used as prescribed.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Asthma-COPD Overlap Syndrome (ACOS), focusing on medications that manage both asthma and COPD symptoms. These include combination inhalers that contain both inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), such as fluticasone/salmeterol and budesonide/formoterol. Additionally, long-acting muscarinic antagonists (LAMA) like tiotropium have been approved for use in ACOS. These treatments align with the goals of the Health Coach-Assisted Consultations trial, which aims to improve access to specialist care and ensure the implementation of specialist recommendations for managing ACOS.

What other types of research exist?

Promising alternatives to Health Coach-Assisted Consultations for ACOS patients include: 1) Collaboration between general practitioners and pulmonologists for proactive diagnosis and management of chronic respiratory diseases, which can improve care coordination and patient outcomes. 2) The use of sublingual immunotherapy (SLIT) for patients with allergic components, which has shown to reduce asthma symptoms and medication use. 3) The Breathlessness Intervention Service, which provides comprehensive management for patients with intractable breathlessness, regardless of the underlying cause, and could be adapted for ACOS patients.

← Back to Search

Health Coach Consultations for Asthma-COPD Overlap Syndrome (PuSHCon Trial)

N/A

Recruiting

Led By Rachel Willard-Grace, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Experiencing uncontrolled symptoms or exacerbations

Must not have

Not having a phone at which the participant can be reached

Cognitive dysfunction that would prevent interaction with a health coach

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new approach where health coaches assist low-income patients with COPD, asthma, or ACOS in following their doctor's advice. The goal is to improve their care and health by ensuring they understand and adhere to specialist recommendations.

Who is the study for?

This trial is for adults over 18 with asthma or COPD who have uncontrolled symptoms or frequent flare-ups. Participants must speak English or Spanish and plan to visit their primary care clinic within the next 3 months. It's not for those already receiving specialist lung care, without a phone, or with cognitive issues preventing them from working with a health coach.

What is being tested?

The study is testing the PuSHCon model where patients get help from health coaches alongside usual care versus just getting usual care. The goal is to see if this extra support improves access to specialist advice and its implementation in treatment plans for low-income patients at public clinics.

What are the potential side effects?

Since this trial involves non-medical interventions like health coaching rather than drugs, traditional side effects are not expected. However, participants may experience changes in stress levels due to increased engagement with healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My symptoms are not under control.

Select...

I have been diagnosed with asthma or COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a phone for contact.

Select...

I can communicate and interact with a health coach without issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Receipt of recommended care

Receipt of recommended medications

Secondary study objectives

Disease specific symptoms score (COPD & Asthma)

Medication adherence

Patient-Reported Disease-specific Quality of Life (for asthma and COPD)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PuSHCon modelExperimental Treatment1 Intervention

A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts,

Group II: Usual careActive Control1 Intervention

Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Asthma-COPD Overlap Syndrome (ACO) involve the combined use of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). ICS work by reducing inflammation in the airways, which is essential for controlling asthma symptoms. LABAs help to relax the muscles around the airways, improving airflow and alleviating COPD symptoms. This combination is particularly effective for ACO patients because it addresses both the inflammatory and bronchoconstrictive components of the disease. Health coaching can further improve outcomes by ensuring that patients adhere to these treatments and follow specialist recommendations, thereby optimizing disease management.

Combined corticosteroid and long acting beta-agonist in one inhaler for chronic obstructive pulmonary disease.