COPD (Chronic Obstructive Pulmonary Disease)RISENCT05572632
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
A study testing COPD Wellness and COPD Wellness Plus+ in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of California, San Francisco at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- COPD Wellness and COPD Wellness Plus+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jan 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Willingness to participate in the COPD Wellness program
- 40 to 90 years old
- English or Spanish speaking
- Physician-diagnosed COPD
- Spirometry-confirmed FEV1/FVC ratio <= 0.7 and FEV1% predicted <80% based on GLI-O prediction equation
Show all 12Show fewer
- COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
- Currently prescribed COPD medication(s)
- Ability to exercise with lower extremities
- No COPD exacerbations for ≥ 6 weeks
- Currently receiving care within SFHN
- Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)
Who cannot join
- Pregnancy
- Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
- Unstable cardiovascular disease (includes recent [<6 months] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
- Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
- Transmittable pulmonary infection (tuberculosis, COVID19)
- Participated in pulmonary rehabilitation in the past 12-months
Show all 9Show fewer
- COPD exacerbation in the past 6 weeks
- Activities restrictions that limit one's ability to engage in moderate physical activity
- Other diagnosis or condition that carry a prognosis of death within the next year
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Zuckerberg San Francisco General (ZSFG) Hospital
San Francisco, California, 94110
Neeta Thakur, MD, MPH, 628-206-8314, neeta.thakur@ucsf.edu
- Recruiting
Maxine Hall Health Center (MHHC)
San Francisco, California, 94115
Migdalia Ordonez, MD
- Recruiting
Southeast Health Center (SEHC)
San Francisco, California, 94124
Keith Seidel, MD
About this study
Official title: Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
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.
The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.
Read the detailed description
The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and explore the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.
- Being tested
- COPD Wellness, COPD Wellness Plus+, Usual Care
- Keywords
- Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD WellnessBehavioural
COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.
COPD Wellness Plus+Behavioural
Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts.
Usual CareBehavioural
Includes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.
| Study group | Role | What they receive |
|---|---|---|
| COPD Wellness | Experimental | This arm, COPD Wellness gives low-intensity exercise component with pulmonary rehabilitation for individuals with moderate-to-severe COPD. COPD Wellness is a program that was built from the Better Breathing Program, that is a part of San Francisco Health Network (SFHN) standard care for COPD. Receives: Behavioral: COPD Wellness |
| Usual Care | Active comparator | This includes access to comprehensive primary care services. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. This program consists of an evidence-based curriculum that improves disease knowledge and management skills but has no effect on symptoms or functional status. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention. Receives: Behavioral: Usual Care |
| COPD Wellness Plus+ | Experimental | This arm includes COPD Wellness Plus+. This arm is built from COPD Wellness with the addition of Health Advocates (i.e. Plus+). This intervention seeks to understand the effects of addressing social needs on overall health and wellness through Zuckerberg San Francisco General Hospital's (ZSFG) Health Advocate (HA) program; participation and engagement with the HA's will serve as an adherence strategy. Receives: Behavioral: COPD Wellness Plus+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
Standardized validated test to measure distance walked in 6 minutes
Measured: 3-month (End of intervention) visit
Secondary outcomes (8)
Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention
Standardized validated test to examine functional status and measure distance walked in 6 minutes (reported in meters)
Measured: Baseline, 6-month, and 9-month visit following end-of-intervention
Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit
Standardized validated comprehensive measure COPD Assessment Test (CAT) of symptom burden for individuals with COPD, minimum score: 0 - maximum score: 40, higher score indicates a more symptomatic COPD
Measured: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit
Health related quality of life is assessed using the validated Short-Form Chronic Respiratory Disease Questionnaire (SF-CRQ). This includes questions about four domains: dyspnea, fatigue, emotional function, and mastery. Items are answered using a 7-point scale Likert scale and summed within each domain. Higher results indicate a higher health-related quality of life.
Measured: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Intervention Adherence at End-of-intervention (3 month)
Adherence as defined by the proportion of sessions attended out of ten
Measured: Assessed during 10-week COPD Wellness Intervention
Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
Self-report non-standardized questionnaire on COPD exacerbation episodes; 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; not scored, higher exacerbations indicate more symptomatic COPD
Measured: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Health System Proportion of patients referred to the intervention
Proportion of patients referred who enroll and participate in the study, which refers to the percent of patients referred that accept (attend 1+ session) COPD Wellness and Plus+ (intervention reach)
Measured: Baseline, 24-months after study implementation
Health System Adoption of intervention for patients referred
Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator
Measured: Baseline, 24-months after study implementation
Healthy System Maintenance of intervention from start of study to end of study activities
Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+
Measured: Baseline, Year 3 of study period (end of study activities)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start19 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Neeta Thakur, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572632
- Sponsor's protocol ID
- 21-35495
- Other IDs
- R01HL161049
- Acronym
- RISE
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified questionnaire data merged with objectively measured data (6 minute walk test) would be shared. To facilitate interpretation of the data, data dictionary, and data collection instruments will be shared and associated with the relevant datasets. To obtain a copy of the data, a researcher will have to submit a request in writing identifying themselves and their affiliated institution, indicate what they plan to do with the data, include assurances that they will not share the data with others without the written permission of the project principal investigator and agree to give proper credit to the project and the investigators who collected the data in any publications resulting from the data. Researchers will have to sign a Data Use Agreement that included these terms, as well as a commitment that they will not attempt to identify individual respondents.
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.
PubMed 10974183Baumann 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.
PubMed 23017153Selzler 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.
PubMed 23030585Fischer 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.
PubMed 19481919Rochester 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.
PubMed 26623686
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
- ClinicalTrials.gov ID
- NCT05572632
- Acronym / sponsor ID
- RISE / 21-35495
- Keywords
- Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.
Detailed description
The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and explore the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Wait-list randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| COPD Wellness | Experimental | Behavioral: COPD WellnessThis arm, COPD Wellness gives low-intensity exercise component with pulmonary rehabilitation for individuals with moderate-to-severe COPD. COPD Wellness is a program that was built from the Better Breathing Program, that is a part of San Francisco Health Network (SFHN) standard care for COPD. |
| Usual Care | Active comparator | Behavioral: Usual CareThis includes access to comprehensive primary care services. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. This program consists of an evidence-based curriculum that improves disease knowledge and management skills but has no effect on symptoms or functional status. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention. |
| COPD Wellness Plus+ | Experimental | Behavioral: COPD Wellness Plus+This arm includes COPD Wellness Plus+. This arm is built from COPD Wellness with the addition of Health Advocates (i.e. Plus+). This intervention seeks to understand the effects of addressing social needs on overall health and wellness through Zuckerberg San Francisco General Hospital's (ZSFG) Health Advocate (HA) program; participation and engagement with the HA's will serve as an adherence strategy. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated informed consent form
- Willingness to participate in the COPD Wellness program
- 40 to 90 years old
- English or Spanish speaking
- Physician-diagnosed COPD
Key exclusion criteria (9 listed)
- Pregnancy
- Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
- Unstable cardiovascular disease (includes recent [<6 months] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
- Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
- Transmittable pulmonary infection (tuberculosis, COVID19)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD WellnessCOPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support. | Behavioural | COPD Wellness |
| COPD Wellness Plus+Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts. | Behavioural | COPD Wellness Plus+ |
| Usual CareIncludes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention. | Behavioural | Usual Care |
Primary outcome
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
Time frame: 3-month (End of intervention) visit
Standardized validated test to measure distance walked in 6 minutes
8 secondary outcomes
Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention
Time frame: Baseline, 6-month, and 9-month visit following end-of-intervention
Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Intervention Adherence at End-of-intervention (3 month)
Time frame: Assessed during 10-week COPD Wellness Intervention
Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Health System Proportion of patients referred to the intervention
Time frame: Baseline, 24-months after study implementation
Health System Adoption of intervention for patients referred
Time frame: Baseline, 24-months after study implementation
Healthy System Maintenance of intervention from start of study to end of study activities
Time frame: Baseline, Year 3 of study period (end of study activities)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 10974183Troosters 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.
- Background: PubMed 23017153Baumann 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.
- Background: PubMed 23030585Selzler 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.
- Background: PubMed 19481919Fischer 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.
- Background: PubMed 26623686Rochester 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.
- Individual participant dataSharing planned: Yes. De-identified questionnaire data merged with objectively measured data (6 minute walk test) would be shared. To facilitate interpretation of the data, data dictionary, and data collection instruments will be shared and associated with the relevant datasets. To obtain a copy of the data, a researcher will have to submit a request in writing identifying themselves and their affiliated institution, indicate what they plan to do with the data, include assurances that they will not share the data with others without the written permission of the project principal investigator and agree to give proper credit to the project and the investigators who collected the data in any publications resulting from the data. Researchers will have to sign a Data Use Agreement that included these terms, as well as a commitment that they will not attempt to identify individual respondents.
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeta Thakur, MD, MPH principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD Wellness and COPD Wellness Plus+ in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neeta Thakur, MD, MPH (628-206-8314, neeta.thakur@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit (time frame: 3-month (End of intervention) visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572632, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.