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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Ichan School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Alex Federman, MD, MPH
alex.federman@mountsinai.org
212-824-7565
Backup
Jennifer Utkin, MS
Jennifer.OschericianUtkin@mountsinai.org
(201) 674-3085
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 300
Treatments
Experimental: Selt-Management Support (SaMBA-COPD)
Participants receiving SaMBA-COPD intervention by community health workers (CHW).~Participants will receive comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation, oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations.
Placebo_comparator: Attention-Matched Support
Participants will receive support by CHWs providing education using the COPD 1-2-3 booklet. Participants will receive similar visit frequencies but will not undergo barrier screening or targeted interventions.
Sponsors
Collaborators: VNS Health, National Heart, Lung, and Blood Institute (NHLBI), Baystate Medical Center
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov