COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources
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.
Interventions
BEHAVIORALCOPD Wellness
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.
BEHAVIORALCOPD 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.
BEHAVIORALUsual Care
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The masked research coordinator will administer questionnaires and conduct clinical assessments at all study visits. Condition assignment will remain masked through data analysis and interpretation from study investigators and any team members involved in the data analysis. Furthermore, the COPD Wellness Coach leading weekly sessions, in addition to the research coordinator collecting endpoint measurements, will be masked to participant group status.
Intervention model description
Wait-list randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit | 3-month (End of intervention) visit | Standardized validated test to measure distance walked in 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Baseline, 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 |
| Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Baseline, 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. |
| Intervention Adherence at End-of-intervention (3 month) | Assessed during 10-week COPD Wellness Intervention | Adherence as defined by the proportion of sessions attended out of ten |
| Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | 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 |
| Health System Proportion of patients referred to the intervention | Baseline, 24-months after study implementation | 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) |
| Health System Adoption of intervention for patients referred | Baseline, 24-months after study implementation | Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator |
| Healthy System Maintenance of intervention from start of study to end of study activities | Baseline, Year 3 of study period (end of study activities) | Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+ |
| Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention | Baseline, 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Social Needs Screening at 3-month (End of Intervention) visit, 6-month, and 9-month follow up | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | Using the Accountable Health Communities (AHC) Health Related Social Needs (HRSN) Screening Tool to assess for food and housing insecurity, transportation issues, and financial strain; standardized and validated; not scored, higher numbers indicate higher social need |
| Change in step count and accelerometry at 3-month (End of Intervention) visit, 6-month, and 9-month follow up | 3-month (End of intervention) visit, 6-month, and 9-month visit | Step count and accelerometry as measured by FitBit Inspire 2 will be compared between the intervention groups (COPD Wellness & Plus+) and the waitlist control group, and between COPD Wellness and Plus+ |
| Change in resting heart rate and heart rate variability at 3-month (End of Intervention) visit, 6-month, and 9-month follow up | 3-month (End of intervention) visit, 6-month, and 9-month visit | Resting heart rate and heart rate variability as measured by Fitbit Inspire 2 will be compared between the intervention groups (COPD Wellness & Plus+) and the waitlist control group, and between COPD Wellness and Plus+ |
| Change from Baseline Medication Adherence at 3-month (End of Intervention), 6-month, and 9-month visit | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | Non-standardized validated questionnaire assessing mean number of days in which patient took all doses of controller medications (i.e., inhalers taken daily to prevent flare ups) as prescribed in last 7 days; seeking Electronic Health Record (EHR)-confirmation of healthcare visit (from COPD Exacerbation History) and medication prescription; not scored |
| Change from Baseline Smoking Status at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | Current use, duration of use, and pack-years will be assessed using the National Health Interview Survey (NHIS) Section IV Part A (Health Behaviors - Tobacco) questionnaire; standardized and validated; not scored |
| Change from Baseline Hospital Anxiety and Depression (HAD) Score at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | 14-item standardized validated questionnaire titled Hospital Anxiety and Depression Scale (HADS) that includes sub-scales on anxiety and depression-- scores added at the end; minimum: 0 - maximum: 21; 0-7 is considered normal, 8-10 is considered borderline abnormal, 11-21 is considered abnormal |
Countries
United States
Contacts
Primary ContactNeeta Thakur, MD, MPH
Backup ContactValeria M Rojas, BS
Outcome results
None listed