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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks after enrollment
Awards & highlights

PuSHCon Trial Summary

This trial is looking at whether or not using health coaches to help people with COPD, asthma, and ACOS can help them better follow specialist recommendations and improve their overall health.

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.Check my eligibility
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.See study design
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.

PuSHCon Trial 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.

PuSHCon Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Receipt of recommended care
Receipt of recommended medications
Secondary outcome measures
Disease specific symptoms score (COPD & Asthma)
Medication adherence
Patient-Reported Disease-specific Quality of Life (for asthma and COPD)
+3 more

PuSHCon 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,195 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,234 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total sample size of this medical trial?

"Affirmative, clinicaltrials.gov's database suggests that this research project is actively seeking participants. It was initially posted on October 20th 2020 and last updated on June 17th 2022. Approximately 360 patients are required for the trial, to be recruited from 10 distinct medical facilities."

Answered by AI

Are investigators currently enrolling participants in this experiment?

"Affirmative. Clinicaltrials.gov's data reveals that this clinical trial, which was initially announced on October 20th 2020, is actively seeking participants. An approximate of 360 subjects need to be recruited from 10 different medical sites."

Answered by AI

What aims is this trial hoping to accomplish?

"The primary aim of this clinical trial, measured over a span of 16 weeks post-enrollment, is to ensure that patients receive their prescribed medication. Secondary objectives include quantifying the disease symptoms through St George's Respiratory Questionnaire symptom subscale (full scoring manual available at http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf), measuring adherence to controller medications over seven days and calculating patient reported quality of care via Patient Assessment of Chronic Illness Care (PACIC) scale 1(Almost Never)-5(Almost"

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Castro Mission Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Pulmonary Specialist-Health Coach Consult Model Study
2020. "Pulmonary Specialist-Health Coach Consult Model Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03695276.
~75 spots leftby Mar 2025
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