Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management (SAMBA COPD)

The Icahn School of Medicine at Mount Sinai will conduct a randomized controlled trial of a self-management support intervention for predominantly minoritized and low-income adults with chronic obstructive pulmonary disease (COPD). The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations. The research team will compare this intervention with an attention control group to evaluate the effects on medication adherence, COPD symptoms, inhaler technique, physical activity and exercise capacity at 6 months, and at 12 months to examine sustainability of treatment effects. The research team will also examine hospitalizations and emergency department visits at 12 months. The study will recruit 300 participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn, ensuring diverse representation. Health coaches from the VNS Health will deliver the intervention, guided by a detailed training manual. Weekly conference calls will address logistical and protocol-related issues.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Self-Management Support; Behavioral: COPD Education

Detailed Description

The Icahn School of Medicine at Mount Sinai is the lead and only site of recruitment for this project. Research study activities will be conducted at practices across the Mount Sinai Health System. The research team will identify a patient pool through the electronic health record. The research team will recruit 300 (150 per arm) participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn in NYC. These practices provide care to a diverse population with considerable sociodemographic diversity (~40% Latino and ~30% Black, ~50% with household incomes <$1,350/month). Randomization will occur 1 month after the baseline interview (and after the devices are returned). Randomization will be in blocks of variable size (4 to 6) and stratified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria B or E. The study's main outcomes will be assessed at 6 months and sustainability of treatment effects at 12 months. The intervention will be delivered by community health workers (CHW)health coaches employed by VNS Health. The research team will follow a detailed intervention training manual and Manual of Operations to guide CHWs through the intervention. The CHWs will also attend a 90-minute monthly group meeting to discuss cases and hear presentations on topics of their choosing for skills and knowledge development. The research team will meet by conference call weekly to discuss logistical issues, refinement of protocol, and other issues pertaining to the study. The project manager will email any modifications to the IRB and research coordinator within one day of receiving approval. The project manager will also email a copy of the amendment approval letter. Mount Sinai will abide by IRB policies as serving site.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Federman, MD, MPH; Phone Number: 212-824-7565; Email: alex.federman@mountsinai.org
• Study Contact Backup: Name: Jennifer Utkin, MS; Phone Number: (201) 674-3085; Email: Jennifer.OschericianUtkin@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Ichan School of Medicine at Mount Sinai
      • Contact: Alex Federman, MD, MPH; Phone Number: 212-824-7565; Email: alex.federman@mountsinai.org
      • Contact: Ruchir Goswami, MBBs, MPH; Phone Number: 212-824-7449; Email: ruchir.goswami2@mountsinai.org
      • Principal Investigator: Alex Federman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥40 years
• Chart-documented COPD with GOLD classifications B or E based on CAT score and number of exacerbations with or without hospitalization determined by electronic health record (EHR) review. GOLD class B and E patients are at increased risk of activity limiting symptoms and exacerbation and are more likely to benefit from the intensive SAMBA-COPD intervention.
• Prescribed a long-acting muscarinic agonist (LAMA), long-acting beta-adrenergic receptor agonist (LABA), an inhaled corticosteroid (ICS), or any combination of these since much of the intervention's focus is on medication adherence.
• English or Spanish speaking

Exclusion Criteria:

• EHR documented dementia, as the research teams focus is on patients with capacity to independently perform self-care tasks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selt-Management Support (SaMBA-COPD); Participants receiving SaMBA-COPD intervention by community health workers (CHW). Participants will receive comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation, oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations.	Behavioral: Self-Management Support; The intervention will be delivered by CHWs in person and supplemented with telephone or video encounters over 6 months. The intervention comprises six core elements: engagement, intake, self-management assessment, barrier screening, actions to address identified barriers, and follow-up/maintenance support.; Other Names: SaMBA-COPD
Placebo Comparator: Attention-Matched Support; Participants will receive support by CHWs providing education using the COPD 1-2-3 booklet. Participants will receive similar visit frequencies but will not undergo barrier screening or targeted interventions.	Behavioral: COPD Education; The attention control is where CHWs will provide COPD education using the COPD 1-2-3 booklet. The attention control will consist of 6 CHW visits (approximately 1 per month) with the patient and care giver in their home or via video conference, per patient preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT) Score	The COPD Assessment Test (CAT) is a validated measure of the impact of COPD on a person's life. COPD symptoms will be measured by self-report using the CAT. Full range from 0-40, with higher scores indicating a more severe impact of COPD on a patient's life.	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of participants who adhere to ≥ 80% of prescribed actuations	Adherence will be measured by the number of participants who adhere to ≥ 80% of prescribed actuations (doses).	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhaler Technique	Participants will be observed performing an inhalation from their COPD controller medication. Participant inhaler technique will be scored using a validated checklist. Higher score indicates better health outcomes. For metered dose and dry powdered inhalers, 0-7 For Ellipta devices, 0-9 For Respimat devices, 0-12	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of steps counted on Actigraph	Physical activity will be measured by total number of steps counted on triaxial accelerometer (Actigraph).	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Quality of life measured using the Clinical COPD Questionnaire (CCQ)	The CCQ is a 10-item questionnaire scored from 0 to 6 for each item (0 being never and 6 being all the time, with higher scores representing worse quality of life). The total score is 0-60.	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of participants with hospitalizations	Number of participants with hospitalizations for COPD-related events obtained from the Statewide Planning and Research Cooperative System (SPARCS).	at Baseline and at 12 months
Number of participants with emergency department (ED) visits	Number of participants with ED visits obtained from the Statewide Planning and Research Cooperative System (SPARCS).	at Baseline and at 12 months
Six Minute Walk Test (6MWT) to measure Exercise Capacity	The 6MWT measures the total the distance walked by the participant over 6 minutes on a closed track.	at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Baystate Medical Center; VNS Health
• Investigators: Principal Investigator: Alex Federman, MD, MPH, Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Publications and helpful links

General Publications

• Agrawal N, Case M, Lindenauer PK, McDermott D, Diaz KM, Utkin JO, Wisnivesky J, Federman A. Protocol for a randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches. Contemp Clin Trials. 2025 Sep 22:108095. doi: 10.1016/j.cct.2025.108095. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Pulmonary Rehabilitation; Coaching; Self Management; Home Based
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: STUDY-23-00838; R01HL171695 (U.S. NIH Grant/Contract); GCO-23-0270 (Other Grant/Funding Number: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Study data will be made available to other users after publication of the study's main results (primary analyses of Aims 1-3). Once made available, no time limit will be placed on accessibility of the study data.
• IPD Sharing Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No