NCT06634810 Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management
| NCT ID | NCT06634810 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-09-25 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Alex Federman, MD, MPH
PRINCIPAL INVESTIGATOR
Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital
Frequently Asked Questions
Who can join the NCT06634810 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06634810 currently recruiting?
Yes, NCT06634810 is actively recruiting participants. Contact the research team at alex.federman@mountsinai.org for enrollment information.
Where is the NCT06634810 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06634810 clinical trial?
NCT06634810 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Alex Federman, MD, MPH at Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital. The trial plans to enroll 300 participants.