NIOSH R21 WTC Asthma

NCT07222501 | Active Not Recruiting DMC

• 1 other identifier: GCO 23-2262
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mini Asthma Quality of Life Questionnaire (AQLQ)

  12 months and 3 months post intervention

• Number of Hospital visits

  12 months and 3 months post intervention

• Number of Emergency Department visits

  12 months and 3 months post intervention

Study Arms (2)

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

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

Interventions

SaMBA BEHAVIORAL

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.

Also known as: Supporting Self-Management Behaviors for Adults

Self Management Support with Lay Health Coaches

Asthma Education - WTC Related BEHAVIORAL

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

Asthma Education - WTC Related

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Juan Wisnivesky, MD, DrPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 30, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (1)