Clinical trial NCT05572632: Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
Official title: Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: Social Needs
Chronic Disease
Health Disparities
Lung Diseases
Community Resources
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-10-10
Enrollment: 387
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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 estimate 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.

Eligibility criteria: Inclusion 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
timeFrame: 3-month (End of intervention) visit
Secondary outcomes:
measure: Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention
timeFrame: Baseline, 6-month, and 9-month visit following end-of-intervention
measure: Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Intervention Adherence at End-of-intervention (3 month)
timeFrame: Assessed during 10-week COPD Wellness Intervention
measure: Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Health System Proportion of patients referred to the intervention
timeFrame: Baseline, 24-months after study implementation
measure: Health System Adoption of intervention for patients referred
timeFrame: Baseline, 24-months after study implementation
measure: Healthy System Maintenance of intervention from start of study to end of study activities
timeFrame: Baseline, Year 3 of study period (end of study activities)
Other outcomes:
measure: Change from Baseline Hospital Anxiety and Depression (HAD) Score at 3-month (End of Intervention) visit, 6-month, and 9-month visit
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change from Baseline Smoking Status at 3-month (End of Intervention) visit, 6-month, and 9-month visit
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change from Baseline Social Needs Screening at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change in step count and accelerometry at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
timeFrame: 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change in resting heart rate and heart rate variability at 3-month (End of Intervention) visit, 6-month, and 9-month follow up
timeFrame: 3-month (End of intervention) visit, 6-month, and 9-month visit
measure: Change from Baseline Medication Adherence at 3-month (End of Intervention), 6-month, and 9-month visit
timeFrame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General (ZSFG) Hospital
state: California
city: San Francisco
country: United States
facility: Maxine Hall Health Center (MHHC)
state: California
city: San Francisco
country: United States
facility: Southeast Health Center (SEHC)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Neeta Thakur, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.