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

NCT06634810 | Recruiting DMC

• 3 other identifiers: STUDY-23-00838R01HL171695GCO-23-0270
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Home Based; Self Management; Pulmonary Rehabilitation; Coaching

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Inhaler Technique

  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

  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)

  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

  at Baseline and at 12 months

• Number of participants with emergency department (ED) visits

  at Baseline and at 12 months

Study Arms (2)

Selt-Management Support (SaMBA-COPD)

EXPERIMENTAL

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

Attention-Matched Support

PLACEBO COMPARATOR

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

Interventions

Self-Management Support BEHAVIORAL

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.

Also known as: SaMBA-COPD

Selt-Management Support (SaMBA-COPD)

COPD Education BEHAVIORAL

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.

Attention-Matched Support

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Baystate Medical Center: collaborator
• VNS Health: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (1)

• 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 Nov;158:108095. doi: 10.1016/j.cct.2025.108095. Epub 2025 Sep 22.

  PMID: 40992542 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Federman, MD, MPH

  Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Federman, MD, MPH

CONTACT

212-824-7565; alex.federman@mountsinai.org

Jennifer Utkin, MS

CONTACT

(201) 674-3085; Jennifer.OschericianUtkin@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research Coordinators conducting interviews, and all investigators will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This project will conduct a randomized controlled trial to evaluate a self-management support intervention for predominantly minoritized, low-income adults with COPD.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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).

Locations

US (1)