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Completed

NCT Number: NCT03287440

Rehabilitation for Patients With COPD

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.

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Key information

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COPD Wellness

Behavioral

This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.

Health Advocate

Behavioral

The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources

Primary outcomes

  1. Change from Baseline 6 Minute Walk Test at End of Intervention

    Time frame: End of Intervention, an average of 4 months

    Standardized test to measure distance walked in 6 minutes

  2. Change from Baseline COPD Assessment Test (CAT) at End of Intervention

    Time frame: End of Intervention, an average of 4 months

    Questionnaire assessing COPD symptoms and quality of life

Secondary outcomes

  1. Change from Baseline number of exacerbations of COPD at End of Intervention

    Time frame: End of Intervention, an average of 4 months

    Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms

  2. Change from Baseline number of exacerbations of COPD at 12 months

    Time frame: 12 months

    Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms

  3. Change in baseline Smoking status at end of intervention

    Time frame: End of Intervention, an average of 4 months

    Have you smoked a cigarette in the past 30 days

  4. Change in baseline Smoking status at 12 months

    Time frame: 12 months

    Have you smoked a cigarette in the past 30 days

  5. Change from baseline D-12 evaluation at end of intervention

    Time frame: End of Intervention, an average of 4 months

    Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms

  6. Change from baseline D-12 evaluation at 12 months

    Time frame: 12 months

    Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms

  7. Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention

    Time frame: End of Intervention, an average of 4 months

    Diagnoses of depressive disorders and depression severity

  8. Adherence

    Time frame: Assessed during 10-week COPD Wellness Intervention

    Number of classes attended by the participant

  9. Change from Baseline 6 Minute Walk Test at 12 months

    Time frame: Baseline and 12 months

    Standardized test to measure distance walked in 6 minutes

  10. Change from Baseline COPD Assessment Test (CAT) at 12 months

    Time frame: Baseline, 12 months

    Measure of COPD symptoms and quality of life

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Kaiser Permanente
  • Nina Ireland Program in Lung Health

Registry information

Official study title

Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD

Acronym: COPD Wellness

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2017
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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