Trials / Active Not Recruiting
Active Not RecruitingNCT07222501
NIOSH R21 WTC Asthma
Comprehensive Self-Management Support for WTC Responders With Asthma
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Asthma Education - WTC Related | 1-3 visits with an asthma educator to receive basic asthma education |
Timeline
- Start date
- 2025-03-03
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2025-10-30
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07222501. Inclusion in this directory is not an endorsement.