Summary

Eligibility
for people ages 40-90 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Neeta Thakur, MD, MPH
Headshot of Neeta Thakur
Neeta Thakur

Description

Summary

Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation. The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.

Official Title

Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD

Details

The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.

Keywords

COPD (Chronic Obstructive Pulmonary Disease), Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, COPD Wellness, COPD Wellness Plus+

Eligibility

You can join if…

Open to people ages 40-90

  • 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
  • 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 upper and/or lower extremities
  • No COPD exacerbations for ≥ 6 weeks
  • Currently receiving care within SFHN
  • Spirometric evidence of obstructive lung disease (FEV1/FVC <70% and FEV1 <80% of predicted).
  • Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)

You CAN'T join if...

  • 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
  • Diagnosis or condition that has a prognosis of 1 year or less for survival

Locations

  • Zuckerberg San Francisco General (ZSFG) Hospital
    San Francisco California 94110 United States
  • Maxine Hall Health Center (MHHC)
    San Francisco California 94115 United States
  • Southeast Health Center (SEHC)
    San Francisco California 94124 United States

Lead Scientist at UCSF

  • Neeta Thakur, MD, MPH
    Dr. Neeta Thakur is a pulmonary and critical care physician at UCSF who examines the role of social and environmental stressors on asthma and COPD in vulnerable populations. Better definitions of the mechanism of how social and environmental stressors impact asthma and COPD will allow for the development of targeted interventions and therapies to improve related outcomes in vulnerable populations.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05572632
Study Type
Interventional
Participants
Expecting 387 study participants
Last Updated