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Active Not RecruitingNCT07222501

NIOSH R21 WTC Asthma

Comprehensive Self-Management Support for WTC Responders With Asthma

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSaMBAThe 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 Related1-3 visits with an asthma educator to receive basic asthma education

Timeline

Start date
2025-03-03
Primary completion
2026-07-01
Completion
2026-07-01
First posted
2025-10-30
Last updated
2026-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07222501. Inclusion in this directory is not an endorsement.