Chronic Obstructive Pulmonary DiseaseCOPD WellnessNCT03287440
Rehabilitation for Patients With COPD
A study testing COPD Wellness and Health Advocate in people with Chronic Obstructive Pulmonary Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD Wellness and Health Advocate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD Wellness, Health Advocate
- Keywords
- Health Disparities, Lung Diseases, Self-management, Chronic Disease, Socio-economic status
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD WellnessBehavioural
This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
Health AdvocateBehavioural
The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COPD Wellness; Behavioral: Health Advocate |
| COPD Wellness | Active comparator | This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD. Receives: Behavioral: COPD Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 6 Minute Walk Test at End of Intervention
Standardized test to measure distance walked in 6 minutes
Measured: 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
Measured: End of Intervention, an average of 4 months
Secondary outcomes (10)
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
Measured: 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
Measured: 12 months
Change in baseline Smoking status at end of intervention
Have you smoked a cigarette in the past 30 days
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Diagnoses of depressive disorders and depression severity
Measured: End of Intervention, an average of 4 months
Adherence
Number of classes attended by the participant
Measured: 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
Measured: Baseline and 12 months
Change from Baseline COPD Assessment Test (CAT) at 12 months
Measure of COPD symptoms and quality of life
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2020
- Study completion30 Jul 2020
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Sequential
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Nina Ireland Program in Lung Health
- Responsible party
- Sponsor
- Investigators
- Neeta Thakur, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287440
- Sponsor's protocol ID
- 16-19967
- Acronym
- COPD Wellness
- Status last verified
- Jun 2022
- First submitted
- 5 Sep 2017
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD
- ClinicalTrials.gov ID
- NCT03287440
- Acronym / sponsor ID
- COPD Wellness / 16-19967
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Health Disparities, Lung Diseases, Self-management, Chronic Disease, Socio-economic status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Nina Ireland Program in Lung Health
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 19 Sep 2017 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| COPD Wellness With Health Advocate | Active comparator | Behavioral: COPD Wellness, Behavioral: Health AdvocateThis 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. |
| COPD Wellness | Active comparator | Behavioral: COPD WellnessThis arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 WellnessThis is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class. | Behavioural | COPD Wellness, COPD Wellness With Health Advocate |
| Health AdvocateThe Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources | Behavioural | COPD Wellness With Health Advocate |
Primary outcome
Change from Baseline 6 Minute Walk Test at End of Intervention
Time frame: End of Intervention, an average of 4 months
Standardized test to measure distance walked in 6 minutes
Change from Baseline COPD Assessment Test (CAT) at End of Intervention
Time frame: End of Intervention, an average of 4 months
Questionnaire assessing COPD symptoms and quality of life
10 secondary outcomes
Change from Baseline number of exacerbations of COPD at End of Intervention
Time frame: End of Intervention, an average of 4 months
Change from Baseline number of exacerbations of COPD at 12 months
Time frame: 12 months
Change in baseline Smoking status at end of intervention
Time frame: End of Intervention, an average of 4 months
Change in baseline Smoking status at 12 months
Time frame: 12 months
Change from baseline D-12 evaluation at end of intervention
Time frame: End of Intervention, an average of 4 months
Change from baseline D-12 evaluation at 12 months
Time frame: 12 months
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Time frame: End of Intervention, an average of 4 months
Adherence
Time frame: Assessed during 10-week COPD Wellness Intervention
Change from Baseline 6 Minute Walk Test at 12 months
Time frame: Baseline and 12 months
Change from Baseline COPD Assessment Test (CAT) at 12 months
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- 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: No
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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. This study is not recruiting at the moment.
Neeta Thakur, MD, MPH principal investigator
University of California, San Francisco
1 site 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 Health Advocate in people with Chronic Obstructive Pulmonary Disease, run by University of California, San Francisco at 1 site 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 6 Minute Walk Test at End of Intervention (time frame: End of Intervention, an average of 4 months). The study lists 2 primary outcomes in all. 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 NCT03287440, 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 3 Jun 2022.