NIOSH R21 WTC Asthma

March 23, 2026 updated by: Juan Wisnivesky, Icahn School of Medicine at Mount Sinai

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asthma Control Test (ACT)
Time Frame: 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.
12 months and 3 months post intervention
Number of times controller inhaler used
Time Frame: 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.
12 months and 3 months post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mini Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: 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.
12 months and 3 months post intervention
Number of Hospital visits
Time Frame: 12 months and 3 months post intervention
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
Time Frame: 12 months and 3 months post intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan Wisnivesky, MD, DrPH, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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