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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
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I am 18 years old or older.
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My symptoms are not under control.
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I have been diagnosed with asthma or COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a phone for contact.
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I can communicate and interact with a health coach without issues.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,901,539 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,941 Previous Clinical Trials
47,792,559 Total Patients Enrolled
Rachel Willard-Grace, MPHPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Asthma-COPD Overlap Syndrome Clinical Trial 2023: PushCon Model Highlights & Side Effects. Trial Name: NCT03695276 — N/A
~20 spots leftby Mar 2025