ClinicalTrials.Veeva

Menu

Rehabilitation for Patients With COPD (COPD Wellness)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Behavioral: Health Advocate
Behavioral: COPD Wellness

Study type

Interventional

Funder types

Other

Identifiers

NCT03287440
16-19967

Details and patient eligibility

About

This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support can improve symptoms and increase physical activity in participants with COPD who receive care within a 'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also receive an adherence strategy targeted at addressing unmet social needs, while the other half will undergo the intervention without the adherence strategy.

Full 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.

COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support, was developed to address this gap. This intervention is targeted at patients with moderate to severe COPD (GOLD Class B-D) who receive care through a safety-net health system. To be impactful, risk factors for low adherence include both disease severity and socio-environmental factors, must be addressed. As merely having a pulmonary rehabilitation program will not automatically lead to improved outcomes.

As part of this study, an adherence strategy targeted at addressing unmet social needs to improve health will also be implemented. A Health Advocates program that links social needs screening with a tiered referral and linkage process to appropriate resources will be tested to see if adherence to COPD Wellness (exercise intervention) improves by addressing competing non-medical stressors.

Enrollment

39 patients

Sex

All

Ages

40 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: Are greater than or equal to 40 years
  • Diagnosis: COPD Gold Stage Class B-D (symptomatic disease), COPD/Asthma overlap with symptoms
  • Language: English
  • Care Center: ZSFG, Community Health Center clinics, Federally Qualified Health Centers
  • Availability: Able to participate in a 10-week, weekly course at the weekly scheduled time (can defer x 1)

Exclusion criteria

  • Planning to move out of the area within the next year
  • Eligible for and desire to go to full intensity pulmonary rehabilitation. Participant has Medicare Part A and B OR have San Francisco Health Plan. For those that met these criteria, we will assist with referral to program
  • Resides in any kind of long-term care facilities that is NOT Laguna Honda or the Mental Health Rehabilitation Facility
  • Has a diagnosis of interstitial lung disease, pulmonary fibrosis, or cystic fibrosis
  • Active, chronic lung infection, such as tuberculosis
  • A history of a pulmonary embolism in the year (12 months) prior to recruitment
  • History of a myocardial infarction in the year (12 months) prior to recruitment
  • In the 12 weeks prior to recruitment, has had history of unstable heart disease (including valve disease), heart failure, or uncontrolled irregular heart beat

Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:

  • A pulmonary exacerbation or worsening of COPD/Asthma symptoms in the past 6 weeks
  • History of an upper respiratory infection in the past 6 weeks
  • History of an eye, chest, or abdominal surgery within the past 6 weeks

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

39 participants in 2 patient groups

COPD Wellness With Health Advocate
Active Comparator group
Description:
This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy.
Treatment:
Behavioral: COPD Wellness
Behavioral: Health Advocate
COPD Wellness
Active Comparator group
Description:
This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
Treatment:
Behavioral: COPD Wellness

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems