AsthmaNCT07222501
NIOSH R21 WTC Asthma
An observational study of Asthma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SaMBA and Asthma Education - WTC Related
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: World Trade Center Responders from the World Trade Center Health Program at Mount Sinai
Who may be able to join
- Age >=21 years;
- English or Spanish speaking;
- World Trade Center-certified asthma;
- on asthma controller medications (as needed or standing);
- uncontrolled asthma.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- SaMBA, Asthma Education - WTC Related
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaMBABehavioural
Also called Supporting Self-Management Behaviors for Adults
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.
Asthma Education - WTC RelatedBehavioural
1-3 visits with an asthma educator to receive basic asthma education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SaMBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months and 3 months post intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start3 Mar 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, DrPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222501
- Sponsor's protocol ID
- GCO 23-2262
- Status last verified
- Mar 2026
- First submitted
- 27 Oct 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Self-Management Support for WTC Responders With Asthma
- ClinicalTrials.gov ID
- NCT07222501
- Acronym / sponsor ID
- GCO 23-2262
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Education - WTC Related | – | Behavioral: Asthma Education - WTC Related1-3 visits with an asthma educator to receive basic asthma education. The number and times of the meetings will be determined by the participant. |
| Self Management Support with Lay Health Coaches | – | Behavioral: SaMBASupporting 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- World Trade Center Responders from the World Trade Center Health Program at Mount Sinai
Key inclusion criteria (5 listed)
- Age >=21 years;
- English or Spanish speaking;
- World Trade Center-certified asthma;
- on asthma controller medications (as needed or standing);
- uncontrolled asthma.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaMBAAlso: Supporting Self-Management Behaviors for AdultsThe 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. | Behavioural | Self Management Support with Lay Health Coaches |
| Asthma Education - WTC Related1-3 visits with an asthma educator to receive basic asthma education | Behavioural | Asthma Education - WTC Related |
Primary outcome
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.
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.
3 secondary outcomes
Mini Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 12 months and 3 months post intervention
Number of Hospital visits
Time frame: 12 months and 3 months post intervention
Number of Emergency Department visits
Time frame: 12 months and 3 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Wisnivesky, MD, DrPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) (time frame: 12 months and 3 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.