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RecruitingNCT07222501

NIOSH R21 WTC Asthma

Comprehensive Self-Management Support for WTC Responders With Asthma

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

58 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

Asthma

Summary

Aim 2: Conduct a pilot RCT of SaMBA-WTC to determine feasibility and preliminary impact in preparation for a fully powered trial. (7M-24M) The investigators will conduct a pilot RCT (n=58) of the SaMBA-WTC model vs. an attention control. Data will be collected on the primary outcomes (asthma control \[asthma control test, ACT\], medication use, inhaler technique) as well as on other secondary outcomes including measures of physical function, self-management behaviors, feasibility and fidelity at baseline, at intervention completion at 3 months, and for sustainability at 6 months. This project will prepare the team for all aspects of a subsequent larger efficacy trial of SaMBA-WTC.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at asthma management in people who responded to the 9/11 World Trade Center disaster and developed certified WTC-related asthma. It aims to understand and improve asthma control in this affected community, many of whom have poorly managed asthma. **You may be eligible if...** - You are 21 or older - You speak English or Spanish - You have WTC-certified asthma (officially diagnosed and registered) - You are currently taking asthma controller medications - Your asthma is not well-controlled despite being on treatment **You may NOT be eligible if...** - You have been diagnosed with dementia by a physician - You have COPD or another chronic lung disease - You have a heavy smoking history (more than 15 pack-years) that could suggest undiagnosed COPD 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

BEHAVIORALSaMBA

The health coach will ask many questions to determine how best to help asthma management and to improve asthma control. The intervention lasts 3 months. During those 3 months, the health coach will speak with participant by phone or video chat several times. Meetings will occur once a week for the first 2-3 weeks, then every 2-4 weeks until the intervention ends. The days and times of the meetings will be up to the participant.

BEHAVIORALAsthma Education - WTC Related

1-3 visits with an asthma educator to receive basic asthma education

Locations(1)

Mount Sinai Hospital

New York, New York, United States

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NCT07222501

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