Clinical trial NCT03187730: Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
Official title: Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Smoking Cassation
Immigrants
Economic Disparity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Erin Rogers
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tempchin J, Vargas E, Sherman S, Rogers E. Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use. Prev Sci. 2023 Apr;24(3):525-534. doi: 10.1007/s11121-022-01416-x. Epub 2022 Aug 6.
citation: Rogers ES, Rosen MI, Elbel B, Wang B, Kyanko K, Vargas E, Wysota CN, Sherman SE. Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial. J Gen Intern Med. 2022 Sep;37(12):2973-2981. doi: 10.1007/s11606-021-07209-2. Epub 2022 Jan 11.