NIOSH R21 WTC Asthma

NCT ID: NCT07222501

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-03

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Asthma Education - WTC Related

Intervention Type BEHAVIORAL

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.

SaMBA

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Asthma Education - WTC Related

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Supporting Self-Management Behaviors for Adults

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Juan Wisnivesky

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Wisnivesky, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Utkin

Role: CONTACT

(201) 674-3085

Facility Contacts

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Jennifer Utkin, MS

Role: primary

212-824-7980

Alex Federman, MD, MPH

Role: backup

Other Identifiers

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GCO 23-2262

Identifier Type: -

Identifier Source: org_study_id

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