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

NCT ID: NCT06634810

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2027-01-31

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.

Detailed Description

The Icahn School of Medicine at Mount Sinai is the lead and only site of recruitment for this project. Research study activities will be conducted at practices across the Mount Sinai Health System. The research team will identify a patient pool through the electronic health record. The research team will recruit 300 (150 per arm) participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn in NYC. These practices provide care to a diverse population with considerable sociodemographic diversity (~40% Latino and ~30% Black, ~50% with household incomes <$1,350/month). Randomization will occur 1 month after the baseline interview (and after the devices are returned). Randomization will be in blocks of variable size (4 to 6) and stratified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria B or E. The study's main outcomes will be assessed at 6 months and sustainability of treatment effects at 12 months. The intervention will be delivered by community health workers (CHW)health coaches employed by VNS Health. The research team will follow a detailed intervention training manual and Manual of Operations to guide CHWs through the intervention. The CHWs will also attend a 90-minute monthly group meeting to discuss cases and hear presentations on topics of their choosing for skills and knowledge development. The research team will meet by conference call weekly to discuss logistical issues, refinement of protocol, and other issues pertaining to the study. The project manager will email any modifications to the IRB and research coordinator within one day of receiving approval. The project manager will also email a copy of the amendment approval letter. Mount Sinai will abide by IRB policies as serving site.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-Management Support

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

COPD Education

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SaMBA-COPD

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baystate Medical Center

OTHER

Sponsor Role: collaborator

VNS Health

UNKNOWN

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Alex D Federman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Federman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Locations

Ichan School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alex Federman, MD, MPH

Role: CONTACT

alex.federman@mountsinai.org

212-824-7565

Jennifer Utkin, MS

Role: CONTACT

Jennifer.OschericianUtkin@mountsinai.org

(201) 674-3085

Facility Contacts

Alex Federman, MD, MPH

Role: primary

alex.federman@mountsinai.org

212-824-7565

Ruchir Goswami, MBBs, MPH

Role: backup

ruchir.goswami2@mountsinai.org

212-824-7449

References

Agrawal N, Case M, Lindenauer PK, McDermott D, Diaz KM, Utkin JO, Wisnivesky J, Federman A. Protocol for a randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches. Contemp Clin Trials. 2025 Sep 22;158:108095. doi: 10.1016/j.cct.2025.108095. Online ahead of print.

Reference Type: DERIVED

PMID: 40992542 (View on PubMed)

Other Identifiers

R01HL171695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO-23-0270

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY-23-00838

Identifier Type: -

Identifier Source: org_study_id