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

NYU Langone Health logo

NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Smoking Cessation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03187730
16-02177

Details and patient eligibility

About

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.

Full 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.

Enrollment

410 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

410 participants in 2 patient groups, including a placebo group

Intervention Arm
Active Comparator group
Treatment:
Behavioral: Integrated Smoking Cessation and Financial Counseling
Drug: Nicotine Replacement Therapy (NRT)
Waitlist Control
Placebo Comparator group
Treatment:
Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling
Drug: Nicotine Replacement Therapy (NRT)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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