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Active, Not Recruiting

NCT Number: NCT07222501

NIOSH R21 WTC 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Supporting Self-Management Behaviors for Adults

Asthma Education - WTC Related

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Comprehensive Self-Management Support for WTC Responders With Asthma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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