Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Documented dementia preventing independent self-care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
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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