Recruiting

COPD Self-management

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06634810

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Self-Management Support

COPD Education

Study Details

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT06634810

Start date

Sep 25, 2024

Status verified date

Sep, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Self-Management Support

The intervention will be delivered by CHWs in person and supplemented with telephone or video encounters over 6 months. The intervention comprises six core elements: engagement, intake, self-management assessment, barrier screening, actions to address identified barriers, and follow-up/maintenance support.

COPD Education

The attention control is where CHWs will provide COPD education using the COPD 1-2-3 booklet. The attention control will consist of 6 CHW visits (approximately 1 per month) with the patient and care giver in their home or via video conference, per patient preference.

Primary outcome measure

  • COPD Assessment Test (CAT) Score [ Time Frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period ]
  • Number of participants who adhere to ≥ 80% of prescribed actuations [ Time Frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period ]

Central Contacts and Locations

Central contacts

Alex Federman, MD, MPH

212-824-7565alex.federman@mountsinai.org

Jennifer Utkin, MS

(201) 674-3085Jennifer.OschericianUtkin@mountsinai.org

Locations

Ichan School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Alex Federman, MD, MPH

212-824-7565alex.federman@mountsinai.org

Ruchir Goswami, MBBs, MPH

212-824-7449ruchir.goswami2@mountsinai.org

Principal Investigator:

Alex Federman

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Keywords

  • COPD
  • Home Based
  • Self Management
  • Pulmonary Rehabilitation
  • Coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-10-06.