COPD study: COPD Wellness vs COPD Wellness Plus+
Official title Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
ClinicalTrials.gov ID: NCT05572632
What this study is testing
- What it's testing
- This study is testing whether a breathing program plus help with daily needs works well. It looks at how this support affects people with COPD.
- Who it's for
- You may be able to join if you have COPD and live in a community with limited health resources.
- What's involved
- You would join a 10-week program to learn about your lungs. You would also get help with social needs and barriers to care.
- Time commitment
- The study lasts 10 weeks and involves joining the wellness program and receiving support.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 90
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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)
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.