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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03187730
• Collaborator: (none)
• Enrollment: 410
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.2
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Integrated Smoking Cessation and Financial Counseling; Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT)	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
• Actual Study Start Date: Sep 22, 2017
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Arm	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.; Drug: Nicotine Replacement Therapy (NRT); Participants in both arms will be eligible to receive a free four-week supply of NRT.
Placebo Comparator: Waitlist Control	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.; Drug: Nicotine Replacement Therapy (NRT); Participants in both arms will be eligible to receive a free four-week supply of NRT.

Outcome Measures

Primary Outcome Measures

1. % 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Erin Rogers, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 26, 2020

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03187730
• Other Study ID Numbers: 16-02177
• First Posted: Jun 15, 2017
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by NYU Langone Health: Smoking Cassation; Immigrants; Economic Disparity
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Intervention Arm	Waitlist Control
Arm/Group Description	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
Period Title: Overall Study
STARTED	208	202
COMPLETED	129	154
NOT COMPLETED	79	48

Baseline Characteristics

Arm/Group Title	Intervention Arm	Waitlist Control	Total
Arm/Group Description	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.	Total of all reporting groups
Overall Participants	208	202	410
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53.2	52.5	52.85
Sex: Female, Male (Count of Participants)
Female	69 33.2%	77 38.1%	146 35.6%
Male	139 66.8%	125 61.9%	264 64.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	105 50.5%	117 57.9%	222 54.1%
Not Hispanic or Latino	103 49.5%	85 42.1%	188 45.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 2.9%	9 4.5%	15 3.7%
Asian	3 1.4%	2 1%	5 1.2%
Native Hawaiian or Other Pacific Islander	1 0.5%	1 0.5%	2 0.5%
Black or African American	98 47.1%	92 45.5%	190 46.3%
White	42 20.2%	39 19.3%	81 19.8%
More than one race	7 3.4%	16 7.9%	23 5.6%
Unknown or Not Reported	51 24.5%	43 21.3%	94 22.9%
Region of Enrollment (participants) [Number]
United States	208 100%	202 100%	410 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Waitlist Control
Arm/Group Description	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
Measure Participants	128	155
Number [% of participants]	27 13%	13 6.4%

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention Arm		Waitlist Control
Arm/Group Description	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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.		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. Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
All Cause Mortality
	Intervention Arm		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/208 (1.4%)		1/202 (0.5%)
Serious Adverse Events
	Intervention Arm		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/208 (5.3%)		5/202 (2.5%)
General disorders
Hospitaliztion	11/208 (5.3%)	11	5/202 (2.5%)	5
Other (Not Including Serious) Adverse Events
	Intervention Arm		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/208 (0%)		0/202 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.