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

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Integrated Smoking Cessation and Financial Counseling; Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT)

• Registration Number: NCT03187730
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2017-09-22
• Primary Completion: 2019-04-30
• Results First Submitted: 2021-03-17
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Results First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

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Exclusion Criteria

• We will exclude participants who report being pregnant or breastfeeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	Nicotine Replacement Therapy (NRT)	-
Intervention Arm	Integrated Smoking Cessation and Financial Counseling	-
Intervention Arm	Nicotine Replacement Therapy (NRT)	-
Waitlist Control	Waitlist Integrated Smoking Cessation and Financial Counseling	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States