Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management
Who can join
Ages 40 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Self-Management Support (behavioral)
- COPD Education (behavioral)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 300 · Started: Sep 25, 2024
Contact the study team
- Alex Federman, MD, MPH · Phone: 212-824-7565
- Jennifer Utkin, MS · Phone: (201) 674-3085
Official record on ClinicalTrials.gov — NCT06634810
Locations in the U.S.
| New York | Ichan School of Medicine at Mount Sinai, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.