Home-based care coaching for managing COPD
Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management
This study is testing a new home-based coaching program to help people with COPD manage their symptoms better and improve their overall health, especially for those from low-income and minoritized backgrounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06634810 on ClinicalTrials.gov |
What this trial studies
This trial, conducted by the Icahn School of Medicine at Mount Sinai, evaluates a self-management support intervention for adults with chronic obstructive pulmonary disease (COPD), particularly targeting minoritized and low-income populations. Participants will receive comprehensive screening and management of barriers to COPD control, including home-based pulmonary rehabilitation and pre-emptive treatment for exacerbations. The study will compare the intervention's effectiveness against an attention control group, measuring outcomes such as medication adherence, COPD symptoms, and exercise capacity over 6 and 12 months. A total of 300 participants will be recruited from diverse communities in Manhattan, Queens, and Brooklyn.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with chart-documented COPD classified as GOLD B or E, who are English or Spanish speaking.
Not a fit: Patients with documented dementia may not benefit from this study due to the focus on self-care capabilities.
Why it matters
Potential benefit: If successful, this intervention could significantly improve self-management and health outcomes for patients with COPD.
How similar studies have performed: Other studies have shown promise with similar self-management interventions for COPD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Ichan School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alex Federman, MD, MPH — Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital
- Study coordinator: Alex Federman, MD, MPH
- Email: alex.federman@mountsinai.org
- Phone: 212-824-7565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.