RecruitingNot ApplicableNCT06634810

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

300 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home-based coaching program called SAMBA-COPD to help people with COPD (chronic obstructive pulmonary disease) better manage their condition on their own. COPD is a serious lung disease causing shortness of breath, and this program focuses on helping patients understand their medications, recognize warning signs, and take steps to stay healthier at home. **You may be eligible if...** - You are 40 years or older - You have been diagnosed with COPD and have moderate-to-high risk disease (GOLD classification B or E) - You are prescribed at least one of these inhalers: LAMA, LABA, or inhaled corticosteroid (ICS) - You speak English or Spanish **You may NOT be eligible if...** - You have documented dementia that prevents you from independently completing self-care tasks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSelf-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.

BEHAVIORALCOPD 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.

Locations(1)

Ichan School of Medicine at Mount Sinai

New York, New York, United States

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NCT06634810

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