Rehabilitation for Patients With COPD

NCT03287440 | Completed

• 1 other identifier: 16-19967
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Health Disparities; Lung Diseases; Self-management; Chronic Disease; Socio-economic status

Outcome Measures

Primary Outcomes (2)

• Change from Baseline 6 Minute Walk Test at End of Intervention

  Standardized test to measure distance walked in 6 minutes

  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

  End of Intervention, an average of 4 months

Secondary Outcomes (10)

• Change from Baseline number of exacerbations of COPD at End of Intervention

  End of Intervention, an average of 4 months

• Change from Baseline number of exacerbations of COPD at 12 months

  12 months

• Change in baseline Smoking status at end of intervention

  End of Intervention, an average of 4 months

• Change in baseline Smoking status at 12 months

  12 months

• Change from baseline D-12 evaluation at end of intervention

  End of Intervention, an average of 4 months

Study Arms (2)

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.

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.

Behavioral: COPD Wellness

Interventions

COPD Wellness BEHAVIORAL

This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.

COPD Wellness; COPD Wellness With Health Advocate

Health Advocate BEHAVIORAL

The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources

COPD Wellness With Health Advocate

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Permanente: collaborator
• Nina Ireland Program in Lung Health: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Related Publications (5)

• 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.

  PMID: 10974183 BACKGROUND

• 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.

  PMID: 23017153 BACKGROUND

• 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.

  PMID: 23030585 BACKGROUND

• 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.

  PMID: 19481919 BACKGROUND

• 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.

  PMID: 26623686 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neeta Thakur, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 19, 2017
• Study Start: September 1, 2017
• Primary Completion: April 30, 2020
• Study Completion: July 30, 2020
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)