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Rehabilitation in Safety-net Settings for Patients With COPD (COPD Wellness)

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ClinicalTrials.gov Identifier: NCT03287440
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Kaiser Permanente
Nina Ireland Program in Lung Health
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Behavioral: COPD Wellness Behavioral: Health Advocate

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

A step-wedge design will allow all participants to receive the intervention. Participants not immediately enrolled into the intervention will serve as controls. At the time of the intervention, these participants will move over to the treatment arm.

The first two groups will be used to refine the COPD Wellness intervention and identify social barriers specific to individuals living with COPD. Starting with group 3, we will alternate the addition of the Health Advocates (HA) program as an adherence strategy in order to determine the HA's effect on participation in COPD Wellness.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.
Primary Purpose: Health Services Research
Official Title: Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: COPD Wellness With Health Advocate
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.
Behavioral: COPD Wellness
This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
Behavioral: Health Advocate
The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
Active Comparator: COPD Wellness
This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
Behavioral: COPD Wellness
This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287440


Contacts
Contact: Emilia Patrick, MSN 415-206-8714 Emilia.Patrick@ucsf.edu
Contact: Neeta Thakur, MD, MPH Neeta.Thakur@ucsf.edu

Locations
United States, California
Zuckerberg San Francisco General Hospital and Trauma Center Recruiting
San Francisco, California, United States, 94110
Contact: Emilia Patrick, MSN    415-206-8714    Emilia.Patrick@ucsf.edu   
Principal Investigator: Neeta Thakur, MD, MPH         
Sponsors and Collaborators
University of California, San Francisco
Kaiser Permanente
Nina Ireland Program in Lung Health
Investigators
Principal Investigator: Neeta Thakur, MD, MPH University of California, San Francisco

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03287440     History of Changes
Other Study ID Numbers: 16-19967
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Health Disparities
Lung Diseases
Self-management
Chronic Disease
Socio-economic status

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases