An interventional study of COPD Wellness and Health Advocate in Chronic Obstructive Pulmonary Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
Among 13 studies in Pulmonary Disease, Chronic Obstructive by University of California, San Francisco — 2 open to participants now, 4 under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · University of California, San Francisco.
Among the 13 studies in Pulmonary Disease, Chronic Obstructive by University of California, San Francisco, this one is the only one that started in 2017, is one of 8 with no phase, and was the 8th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →2 of the 13 studies in Pulmonary Disease, Chronic Obstructive by University of California, San Francisco are open now, in 1 country. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 40–90
University of California, San Francisco · Sites in United States
Ages 40–75 · Healthy volunteers
By country, each count listing its studies:
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 40 Years to 95 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
This study's enrollment of 39 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 125 across the 9 interventional studies, 175 across the 3 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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University of California, San Francisco is the lead sponsor of 2,170 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
2 of the studies in Pulmonary Disease, Chronic Obstructive by University of California, San Francisco that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05572632University of California, San FranciscoRehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD | 2026-12-31 |
| NCT06152653University of California, San FranciscoThe Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM) | 2027-04 |
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Among the 13 studies in Pulmonary Disease, Chronic Obstructive by University of California, San Francisco, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Health Advocate
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.
The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
Change from Baseline 6 Minute Walk Test at End of Intervention
Standardized test to measure distance walked in 6 minutes
Time frame: 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
Time frame: End of Intervention, an average of 4 months
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
Time frame: 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
Time frame: 12 months
Change in baseline Smoking status at end of intervention
Have you smoked a cigarette in the past 30 days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Diagnoses of depressive disorders and depression severity
Time frame: End of Intervention, an average of 4 months
Adherence
Number of classes attended by the participant
Time frame: 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
Time frame: Baseline and 12 months
Change from Baseline COPD Assessment Test (CAT) at 12 months
Measure of COPD symptoms and quality of life
Time frame: Baseline, 12 months
Plan to share: No
Ran from Sep 2017 to primary completion in Apr 2020, 31 months.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 31 months is above that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
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