NCT01123967

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

May 12, 2010

Last Update Submit

May 26, 2015

Conditions

Tobacco Use Cessation

Keywords

nicotine replacement therapysmoking cessationtobacco dependent

Outcome Measures

Primary Outcomes (1)

  • Results in Abstinence Rates

    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 Outcomes (2)

  • Results in Treatment Utilization

    1 Year

  • Cost-Effectiveness of Program

    1 Year

Study Arms (2)

PRO+NRT+TC

EXPERIMENTAL

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)Other: telephone counseling (TC)Other: Nicotine replacement therapy (NRT)

Usual Care (UC)

ACTIVE COMPARATOR

Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray

Other: Usual care (UC)

Interventions

proactive outreach (PRO)OTHER

a mailed invitation letter followed by telephone outreach

PRO+NRT+TC
telephone counseling (TC)OTHER

free telephone counseling

PRO+NRT+TC
Nicotine replacement therapy (NRT)OTHER

free nicotine replacement therapy (NRT)

PRO+NRT+TC
Usual care (UC)OTHER

nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Usual Care (UC)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steven Fu, M.D.

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (4)

  • Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.

    PMID: 32614201DERIVED

  • Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.

    PMID: 31363948DERIVED

  • Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.

    PMID: 26931362DERIVED

  • Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.

    PMID: 24716466DERIVED

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Steven Fu, M.D.

    Veterans Administration Hospital

    PRINCIPAL INVESTIGATOR

  • Anne Joseph, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

August 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)