NIOSH R21 WTC Asthma

Comprehensive Self-Management Support for WTC Responders With Asthma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Asthma Education - WTC Related; Behavioral: SaMBA

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

World Trade Center Responders from the World Trade Center Health Program at Mount Sinai

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma Education - WTC Related; 1-3 visits with an asthma educator to receive basic asthma education. The number and times of the meetings will be determined by the participant.	Behavioral: Asthma Education - WTC Related; 1-3 visits with an asthma educator to receive basic asthma education
Self Management Support with Lay Health Coaches; Supporting Self-Management Behaviors for Adults (SaMBA) program. The SaMBA model of SMS is an evidence-based approach grounded in a theory of health behavior, the Self-regulation Model (SRM), and a conceptual model of health care use, the Aday-Anderson model. SaMBA is unique among chronic illness SMS programs because its strategy involves comprehensively screening for barriers to effective self-management and disease control and couples it with tailored, theory-based, barrier specific interventions.	Behavioral: SaMBA; 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.; Other Names: Supporting Self-Management Behaviors for Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test (ACT)	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.	12 months and 3 months post intervention
Number of times controller inhaler used	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.	12 months and 3 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Asthma Quality of Life Questionnaire (AQLQ)	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.	12 months and 3 months post intervention
Number of Hospital visits	Any hospital visits at every research visit will be track by use of survey in REDCap.	12 months and 3 months post intervention
Number of Emergency Department visits	Any emergency visits at every research visit will be track by use of survey in REDCap.	12 months and 3 months post intervention

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Juan Wisnivesky, MD, DrPH, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 27, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: GCO 23-2262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to juan.wisnivesky@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No