Offering Proactive Tobacco Treatment

May 26, 2015 updated by: University of Minnesota

Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).

Study Type

Interventional

Enrollment (Actual)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Steven Fu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must complete the baseline survey
  • Current self-reported cigarette smoker
  • Has a valid home address
  • An adequate proficiency in English to complete study surveys and participate in telephone counseling.

exclusion Criteria:

  • adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO+NRT+TC
Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC)
Other: proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
Other: telephone counseling (TC)
free telephone counseling
Other: Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
Active Comparator: Usual Care (UC)
Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
Other: Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results in Abstinence Rates
Time Frame: 1 Year
Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results in Treatment Utilization
Time Frame: 1 Year
Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers.
1 Year
Cost-Effectiveness of Program
Time Frame: 1 Year
Determine the cost-effectiveness of PRO+NRT+TC compared with UC.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steven Fu, M.D., Veterans Administration Hospital
  • Principal Investigator: Anne Joseph, MD, Masonic Cancer Center, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009NTLS064
  • 0909S72235 (Other Identifier: IRB, University of Minnesota)
  • 1R01CA141527 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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