Asthma
Conditions
Brief 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.
Interventions
BEHAVIORALSaMBA
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.
BEHAVIORALAsthma Education - WTC Related
1-3 visits with an asthma educator to receive basic asthma education
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mini Asthma Quality of Life Questionnaire (AQLQ) | 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. |
| Number of Hospital visits | 12 months and 3 months post intervention | Any hospital visits at every research visit will be track by use of survey in REDCap. |
| Number of Emergency Department visits | 12 months and 3 months post intervention | Any emergency visits at every research visit will be track by use of survey in REDCap. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJuan Wisnivesky, MD, DrPH
Icahn School of Medicine at Mount Sinai
Outcome results
None listed