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

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ClinicalTrials.gov Identifier: NCT03187730
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : September 22, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of quitting smoking attempts [ Time Frame: 12 Months ]
    A study team member will make 10 attempts over 4 weeks to complete the survey. The surveys will re-assess participant behavior and characteristic assessed at baseline, and a short series of close-ended and open-ended questions about satisfaction with the interventions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187730


Contacts
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Contact: Elizabeth Vargas 646 501 2545 Elizabeth.Vargas@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Elizabeth Vargas    646-501-2545    Elizabeth.Vargas@nyumc.org   
Principal Investigator: Erin Rogers, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Erin Rogers NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03187730     History of Changes
Other Study ID Numbers: 16-02177
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

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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:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action