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Rehabilitation for Patients With COPD (COPD Wellness)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPD Wellness
Health Advocate
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring Health Disparities, Lung Diseases, Self-management, Chronic Disease, Socio-economic status

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

COPD Wellness With Health Advocate

COPD Wellness

Arm 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.

This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.

Outcomes

Primary Outcome Measures

Change from Baseline 6 Minute Walk Test at End of Intervention
Standardized test to measure distance walked in 6 minutes
Change from Baseline COPD Assessment Test (CAT) at End of Intervention
Questionnaire assessing COPD symptoms and quality of life

Secondary Outcome Measures

Change from Baseline number of exacerbations of COPD at End of Intervention
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
Change from Baseline number of exacerbations of COPD at 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
Change in baseline Smoking status at end of intervention
Have you smoked a cigarette in the past 30 days
Change in baseline Smoking status at 12 months
Have you smoked a cigarette in the past 30 days
Change from baseline D-12 evaluation at end of intervention
Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Change from baseline D-12 evaluation at 12 months
Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Diagnoses of depressive disorders and depression severity
Adherence
Number of classes attended by the participant
Change from Baseline 6 Minute Walk Test at 12 months
Standardized test to measure distance walked in 6 minutes
Change from Baseline COPD Assessment Test (CAT) at 12 months
Measure of COPD symptoms and quality of life

Full Information

First Posted
September 5, 2017
Last Updated
June 1, 2022
Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente, Nina Ireland Program in Lung Health
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1. Study Identification

Unique Protocol Identification Number
NCT03287440
Brief Title
Rehabilitation for Patients With COPD
Acronym
COPD Wellness
Official Title
Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente, Nina Ireland Program in Lung Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Health Disparities, Lung Diseases, Self-management, Chronic Disease, Socio-economic status

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD Wellness With Health Advocate
Arm Type
Active Comparator
Arm 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.
Arm Title
COPD Wellness
Arm Type
Active Comparator
Arm Description
This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
Intervention Type
Behavioral
Intervention Name(s)
COPD Wellness
Intervention Description
This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
Intervention Type
Behavioral
Intervention Name(s)
Health Advocate
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline 6 Minute Walk Test at End of Intervention
Description
Standardized test to measure distance walked in 6 minutes
Time Frame
End of Intervention, an average of 4 months
Title
Change from Baseline COPD Assessment Test (CAT) at End of Intervention
Description
Questionnaire assessing COPD symptoms and quality of life
Time Frame
End of Intervention, an average of 4 months
Secondary Outcome Measure Information:
Title
Change from Baseline number of exacerbations of COPD at End of Intervention
Description
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
Time Frame
End of Intervention, an average of 4 months
Title
Change from Baseline number of exacerbations of COPD at 12 months
Description
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
Time Frame
12 months
Title
Change in baseline Smoking status at end of intervention
Description
Have you smoked a cigarette in the past 30 days
Time Frame
End of Intervention, an average of 4 months
Title
Change in baseline Smoking status at 12 months
Description
Have you smoked a cigarette in the past 30 days
Time Frame
12 months
Title
Change from baseline D-12 evaluation at end of intervention
Description
Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Time Frame
End of Intervention, an average of 4 months
Title
Change from baseline D-12 evaluation at 12 months
Description
Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Time Frame
12 months
Title
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Description
Diagnoses of depressive disorders and depression severity
Time Frame
End of Intervention, an average of 4 months
Title
Adherence
Description
Number of classes attended by the participant
Time Frame
Assessed during 10-week COPD Wellness Intervention
Title
Change from Baseline 6 Minute Walk Test at 12 months
Description
Standardized test to measure distance walked in 6 minutes
Time Frame
Baseline and 12 months
Title
Change from Baseline COPD Assessment Test (CAT) at 12 months
Description
Measure of COPD symptoms and quality of life
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Thakur, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital and Trauma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10974183
Citation
Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am J Med. 2000 Aug 15;109(3):207-12. doi: 10.1016/s0002-9343(00)00472-1.
Results Reference
background
PubMed Identifier
23017153
Citation
Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.
Results Reference
background
PubMed Identifier
23030585
Citation
Selzler AM, Simmonds L, Rodgers WM, Wong EY, Stickland MK. Pulmonary rehabilitation in chronic obstructive pulmonary disease: predictors of program completion and success. COPD. 2012 Aug;9(5):538-45. doi: 10.3109/15412555.2012.705365.
Results Reference
background
PubMed Identifier
19481919
Citation
Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, Weinman J, Rabe KF, Kaptein AA. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med. 2009 Oct;103(10):1564-71. doi: 10.1016/j.rmed.2008.11.020. Epub 2009 May 29.
Results Reference
background
PubMed Identifier
26623686
Citation
Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
Results Reference
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Rehabilitation for Patients With COPD

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