Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

Study Overview
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Brief Summary
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This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.

Detailed Description
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This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.

Official Title
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Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Integrated Smoking Cessation and Financial Counseling
* Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling
* Drug: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokes ≥5 cigarettes per day Born outside the U.S. Interested in receiving smoking and financial counseling Self-reported income below 200% of the current federal poverty level for a given household composition New York City resident English or Spanish language Able to provide informed consent, and Does not have a representative who manages his/her funds (to ensure the participant has the ability to manage household money). We will exclude participants who report being pregnant or breastfeeding (unable to receive NRT). Hospital staff participants: Must be current medical or non-medical provider or administrator at Bellevue Hospital or New York University Lutheran Medical Center Exclusion Criteria: We will exclude participants who report being pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br> | Behavioral: Integrated Smoking Cessation and Financial Counseling<br>* Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.<br>Drug: Nicotine Replacement Therapy (NRT)<br>* Participants in both arms will be eligible to receive a free four-week supply of NRT.<br>|
| Placebo Comparator: Waitlist Control<br> | Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling<br>* Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.<br>Drug: Nicotine Replacement Therapy (NRT)<br>* Participants in both arms will be eligible to receive a free four-week supply of NRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) | Participants answered In the past 7 days, have you smoked a cigarette? (yes/no); % of yes is reported per arm | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cassation, Immigrants, Economic Disparity