Improving outcomes for vulnerable COPD patients through a wellness program

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a 10-week COPD Wellness and Plus+ Program compared to usual care for patients with chronic obstructive pulmonary disease (COPD) in underserved communities. It incorporates a Health Advocates program to address social needs and barriers to healthcare, aiming to improve functional and symptom outcomes. The trial is designed as a three-arm, randomized waitlist-controlled study conducted in urban primary care sites that serve socially vulnerable populations. The implementation of the program will be assessed using established frameworks to identify barriers and enablers to patient acceptance and adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Willingness to participate in the COPD Wellness program
* 40 to 90 years old
* English or Spanish speaking
* Physician-diagnosed COPD
* Spirometry-confirmed FEV1/FVC ratio \<= 0.7 and FEV1% predicted \<80% based on GLI-O prediction equation
* COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
* Currently prescribed COPD medication(s)
* Ability to exercise with lower extremities
* No COPD exacerbations for ≥ 6 weeks
* Currently receiving care within SFHN

  * Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)

Exclusion Criteria:

* Pregnancy
* Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
* Unstable cardiovascular disease (includes recent \[\<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
* Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
* Transmittable pulmonary infection (tuberculosis, COVID19)
* Participated in pulmonary rehabilitation in the past 12-months
* COPD exacerbation in the past 6 weeks
* Activities restrictions that limit one's ability to engage in moderate physical activity
* Other diagnosis or condition that carry a prognosis of death within the next year

Where it's running

• Zuckerberg San Francisco General (ZSFG) Hospital
  San Francisco, California, United States Recruiting
• Maxine Hall Health Center (MHHC)
  San Francisco, California, United States Recruiting
• Southeast Health Center (SEHC)
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Neeta Thakur, MD, MPH — University of California, San Francisco
• Study coordinator: Neeta Thakur, MD, MPH
• Email: neeta.thakur@ucsf.edu
• Phone: 628-206-8314

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.