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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months and 3 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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World Trade Center Responders from the World Trade Center Health Program at Mount Sinai
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| Name | Affiliation | Role |
|---|---|---|
| Juan Wisnivesky, MD, DrPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to juan.wisnivesky@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
|
| Asthma Education - WTC Related | Behavioral | 1-3 visits with an asthma educator to receive basic asthma education |
|
| 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. | 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. | 12 months and 3 months post intervention |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |