RECRUITING

Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-01-19
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05572632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Willingness to participate in the COPD Wellness program
  3. * 40 to 90 years old
  4. * English or Spanish speaking
  5. * Physician-diagnosed COPD
  6. * Spirometry-confirmed FEV1/FVC ratio \<= 0.7 and FEV1% predicted \<80% based on GLI-O prediction equation
  7. * COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
  8. * Currently prescribed COPD medication(s)
  9. * Ability to exercise with lower extremities
  10. * No COPD exacerbations for ≥ 6 weeks
  11. * Currently receiving care within SFHN
  12. * Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)
  1. * Pregnancy
  2. * Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
  3. * Unstable cardiovascular disease (includes recent \[\<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
  4. * Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
  5. * Transmittable pulmonary infection (tuberculosis, COVID19)
  6. * Participated in pulmonary rehabilitation in the past 12-months
  7. * COPD exacerbation in the past 6 weeks
  8. * Activities restrictions that limit one's ability to engage in moderate physical activity
  9. * Other diagnosis or condition that carry a prognosis of death within the next year

Contacts and Locations

Study Contact

Neeta Thakur, MD, MPH
CONTACT
628-206-8314
neeta.thakur@ucsf.edu
Valeria M Rojas, BS
CONTACT
408-840-1971
Valeria.rojas@ucsf.edu

Principal Investigator

Neeta Thakur, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Neeta Thakur, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-01-19
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Social Needs
  • Chronic Disease
  • Health Disparities
  • Lung Diseases
  • Community Resources

Additional Relevant MeSH Terms

  • COPD (Chronic Obstructive Pulmonary Disease)