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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2021-04-30

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.

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Arm

Group Type ACTIVE_COMPARATOR

Integrated Smoking Cessation and Financial Counseling

Intervention Type BEHAVIORAL

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.

Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

Participants in both arms will be eligible to receive a free four-week supply of NRT.

Waitlist Control

Group Type PLACEBO_COMPARATOR

Waitlist Integrated Smoking Cessation and Financial Counseling

Intervention Type BEHAVIORAL

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.

Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

Participants in both arms will be eligible to receive a free four-week supply of NRT.

Interventions

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Integrated Smoking Cessation and Financial Counseling

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.

Intervention Type BEHAVIORAL

Waitlist Integrated Smoking Cessation and Financial Counseling

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.

Intervention Type BEHAVIORAL

Nicotine Replacement Therapy (NRT)

Participants in both arms will be eligible to receive a free four-week supply of NRT.

Intervention Type DRUG

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