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Home-based Care Coaching for COPD Self-management

This study is testing two different approaches to help people with Chronic Obstructive Pulmonary Disease (COPD) better manage their condition at home. One group will receive "Self-Management Support," which involves community health workers (CHWs) helping you identify and overcome challenges to managing your COPD, including home-based pulmonary rehabilitation. The other group will receive "COPD Education" from CHWs using a specific booklet. The goal is to see if these interventions improve how well you take your medications and your COPD symptoms. You may be able to join if you are 40 or older and have chart-documented COPD with a GOLD classification of B or E. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is a randomized controlled trial comparing two behavioral interventions, with 300 participants planned across two groups.
What's involved
You will have approximately six visits with a community health worker over six months, either in your home or via video conference.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be checked at the end of the 6-month treatment period and again 6 months after treatment ends, for a total of 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06634810

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

Recruiting
NAAges 40+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~300 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Self-Management SupportCOPD Education

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
COPD Assessment Test (CAT) Score
Measured over 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
+1 more outcome measured

Conditions

Chronic Obstructive Pulmonary Disease

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Chronic Obstructive Pulmonary Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Alex Federman, MD, MPH
[email protected]
212-824-7565
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

EHR documented dementia, as the research teams focus is on patients with capacity to independently perform self-care tasks.

What this trial measures

  • COPD Assessment Test (CAT) Scoreat baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period

    The COPD Assessment Test (CAT) is a validated measure of the impact of COPD on a person's life. COPD symptoms will be measured by self-report using the CAT. Full range from 0-40, with higher scores indicating a more severe impact of COPD on a patient's life.

  • Number of participants who adhere to ≥ 80% of prescribed actuationsat baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period

    Adherence will be measured by the number of participants who adhere to ≥ 80% of prescribed actuations (doses).