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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187730
• Other study ID #: 16-02177
• Status: Completed
• Phase: Phase 4
• Start date: September 22, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.
• 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.

Drug:
• Nicotine Replacement Therapy (NRT)
Participants in both arms will be eligible to receive a free four-week supply of NRT.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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