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Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Primary Purpose

COPD (Chronic Obstructive Pulmonary Disease)

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

COPD Wellness

COPD Wellness Plus+

Usual Care

About this trial

This is an interventional health services research trial for COPD (Chronic Obstructive Pulmonary Disease) focused on measuring Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zuckerberg San Francisco General (ZSFG) HospitalRecruiting
Maxine Hall Health Center (MHHC)
Southeast Health Center (SEHC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

COPD Wellness

Usual Care

COPD Wellness Plus+

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit

Standardized validated test to measure distance walked in 6 minutes

Secondary Outcome Measures

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)

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

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.

Intervention Adherence at End-of-intervention (3 month)

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

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

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

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

Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+

Full Information

NCT ID

NCT05572632

First Posted

September 22, 2022

Last Updated

September 22, 2023

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT05572632

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Wait-list randomized controlled trial.

Masking

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

387 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD Wellness

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Arm Title

COPD Wellness Plus+

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

COPD Wellness

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

COPD Wellness Plus+

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit

Description

Standardized validated test to measure distance walked in 6 minutes

Time Frame

3-month (End of intervention) visit

Secondary Outcome Measure Information:

Title

Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention

Description

Standardized validated test to examine functional status and measure distance walked in 6 minutes (reported in meters)

Time Frame

Baseline, 6-month, and 9-month visit following end-of-intervention

Title

Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit

Description

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit

Description

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Intervention Adherence at End-of-intervention (3 month)

Description

Adherence as defined by the proportion of sessions attended out of ten

Time Frame

Assessed during 10-week COPD Wellness Intervention

Title

Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up

Description

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Health System Proportion of patients referred to the intervention

Description

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)

Time Frame

Baseline, 24-months after study implementation

Title

Health System Adoption of intervention for patients referred

Description

Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator

Time Frame

Baseline, 24-months after study implementation

Title

Healthy System Maintenance of intervention from start of study to end of study activities

Description

Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+

Time Frame

Baseline, Year 3 of study period (end of study activities)

Other Pre-specified Outcome Measures:

Title

Change from Baseline Hospital Anxiety and Depression (HAD) Score at 3-month (End of Intervention) visit, 6-month, and 9-month visit

Description

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

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change from Baseline Smoking Status at 3-month (End of Intervention) visit, 6-month, and 9-month visit

Description

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

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change from Baseline Social Needs Screening at 3-month (End of Intervention) visit, 6-month, and 9-month follow up

Description

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

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change in step count and accelerometry at 3-month (End of Intervention) visit, 6-month, and 9-month follow up

Description

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+

Time Frame

3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change in resting heart rate and heart rate variability at 3-month (End of Intervention) visit, 6-month, and 9-month follow up

Description

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+

Time Frame

3-month (End of intervention) visit, 6-month, and 9-month visit

Title

Change from Baseline Medication Adherence at 3-month (End of Intervention), 6-month, and 9-month visit

Description

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

Time Frame

Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Neeta Thakur, MD, MPH

Phone

628-206-8314

neeta.thakur@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Valeria M Rojas, BS

Phone

408-840-1971

Valeria.rojas@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neeta Thakur, MD, MPH

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zuckerberg San Francisco General (ZSFG) Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neeta Thakur, MD, MPH

Phone

628-206-8314

neeta.thakur@ucsf.edu

Facility Name

Maxine Hall Health Center (MHHC)

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Migdalia Ordonez, MD

Facility Name

Southeast Health Center (SEHC)

City

San Francisco

State/Province

California

ZIP/Postal Code

94124

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keith Seidel, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10974183

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.

Results Reference

background

PubMed Identifier

23017153

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.

Results Reference

background

PubMed Identifier

23030585

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.

Results Reference

background

PubMed Identifier

19481919

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.

Results Reference

background

PubMed Identifier

26623686

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.

Results Reference

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Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

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