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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| Nina Ireland Program in Lung Health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD Wellness With Health Advocate | Active Comparator | 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. |
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| COPD Wellness | Active Comparator | This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPD Wellness | Behavioral | This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:
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| Name | Affiliation | Role |
|---|---|---|
| Neeta Thakur, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10974183 | Background | 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. | |
| 23017153 | Background | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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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.
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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.
| 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 |
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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 |
| 23030585 | Background | 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. |
| 19481919 | Background | 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. |
| 26623686 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |