Offering Proactive Tobacco Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01123967
First received: May 12, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Tobacco Use Cessation
Other: proactive outreach (PRO)
Other: telephone counseling (TC)
Other: Nicotine replacement therapy (NRT)
Other: Usual care (UC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Results in Abstinence Rates [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Results in Treatment Utilization [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.

  • Cost-Effectiveness of Program [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Determine the cost-effectiveness of PRO+NRT+TC compared with UC.


Enrollment: 2500
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123967

Locations
United States, Minnesota
Steven Fu, M.D.
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Steven Fu, M.D. Veterans Administration Hospital
Principal Investigator: Anne Joseph, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01123967     History of Changes
Other Study ID Numbers: 2009NTLS064, 0909S72235, 1R01CA141527
Study First Received: May 12, 2010
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
nicotine replacement therapy
smoking cessation
tobacco dependent

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014