Rehabilitation for Patients With COPD (COPD Wellness)

Pilot Study of Rehabilitation in Safety-net Settings 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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: 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
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital and Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline 6 Minute Walk Test at End of Intervention	Standardized test to measure distance walked in 6 minutes	End of Intervention, an average of 4 months
Change from Baseline COPD Assessment Test (CAT) at End of Intervention	Questionnaire assessing COPD symptoms and quality of life	End of Intervention, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	End of Intervention, an average of 4 months
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	12 months
Change in baseline Smoking status at end of intervention	Have you smoked a cigarette in the past 30 days	End of Intervention, an average of 4 months
Change in baseline Smoking status at 12 months	Have you smoked a cigarette in the past 30 days	12 months
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	End of Intervention, an average of 4 months
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	12 months
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention	Diagnoses of depressive disorders and depression severity	End of Intervention, an average of 4 months
Adherence	Number of classes attended by the participant	Assessed during 10-week COPD Wellness Intervention
Change from Baseline 6 Minute Walk Test at 12 months	Standardized test to measure distance walked in 6 minutes	Baseline and 12 months
Change from Baseline COPD Assessment Test (CAT) at 12 months	Measure of COPD symptoms and quality of life	Baseline, 12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Kaiser Permanente; Nina Ireland Program in Lung Health
• Investigators: Principal Investigator: Neeta Thakur, MD, MPH, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Lung Diseases; Health Disparities; Self-management; Chronic Disease; Socio-economic status
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 16-19967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No