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NIOSH R21 WTC Asthma

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Mount Sinai Health System

Status

Enrolling

Conditions

Asthma

Treatments

Behavioral: Asthma Education - WTC Related
Behavioral: SaMBA

Study type

Observational

Funder types

Other

Identifiers

NCT07222501
GCO 23-2262

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

58 participants in 2 patient groups

Asthma Education - WTC Related
Description:
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.
Treatment:
Behavioral: Asthma Education - WTC Related
Self Management Support with Lay Health Coaches
Description:
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.
Treatment:
Behavioral: SaMBA

Trial contacts and locations

1

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Central trial contact

Jennifer Utkin

Data sourced from clinicaltrials.gov

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