NIOSH R21 WTC Asthma

Recruiting

• Conditions: Asthma

• Registration Number: NCT07222501
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-03
• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-30
• Primary Completion: 2026-03-03
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Age >=21 years;
• English or Spanish speaking;
• World Trade Center-certified asthma;
• on asthma controller medications (as needed or standing);
• uncontrolled asthma.

Exclusion Criteria

• Physician's diagnosis of dementia,
• COPD or other chronic pulmonary disease,
• >15 pack-years history of smoking to avoid enrolling WTC responders with undiagnosed COPD.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	12 months and 3 months post intervention	Asthma control test assesses how well asthma is controlled over the past four weeks. Total score range from 5-25, with higher score indicating better health outcomes.
Number of times controller inhaler used	12 months and 3 months post intervention	Medication use will be measured with electronic monitors attached to the participant's control inhaler. Adherence will be measured by use of the electronic monitors that will capture how often the participant uses their controller inhaler.

Secondary Outcome Measures

Name	Time	Method
Mini Asthma Quality of Life Questionnaire (AQLQ)	12 months and 3 months post intervention	The validated Mini Asthma Quality of Life Questionnaire (AQLQ) is available in English and Spanish. The 15-item questionnaire measures quality of life in the domains of symptoms, activity limitation, emotional function, and environmental stimuli. Items are scored on a 7-point scale from severely impaired to not impaired at all. Each domain scores and full scores range 1-7, with higher scores indicating better quality of life.
Number of Hospital visits	12 months and 3 months post intervention	Any hospital visits at every research visit will be track by use of survey in REDCap.
Number of Emergency Department visits	12 months and 3 months post intervention	Any emergency visits at every research visit will be track by use of survey in REDCap.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States