Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06634810

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-10-06

300

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

B

Baystate Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • Chart-documented COPD with GOLD classifications B or E based on CAT score and exacerbations
  • Prescribed a long-acting muscarinic agonist, long-acting beta-adrenergic agonist, inhaled corticosteroid, or combination
  • English or Spanish speaking
Not Eligible

You will not qualify if you...

  • Documented dementia preventing independent self-care

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ichan School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

A

Alex Federman, MD, MPH

CONTACT

J

Jennifer Utkin, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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