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

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

• Baystate Medical Center

  collaborator OTHER

• VNS Health

  collaborator UNKNOWN

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Alex Federman, MD, MPH · Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-25

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• United States

Study Locations