Connect to Quit for Smoking

NCT01299896 | Completed Results

• 2 other identifiers: 02936R01CA141596
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.

Conditions

Smoking; Smoking Cessation

Keywords

Cigarette Smoking; Smoking, Tobacco; Tobacco Smoking; Smoking Cessation; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Effectiveness of CTQ vs UC

  We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.

  Two (2) year period

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.

Other: Usual Care

Coordinated Care

ACTIVE COMPARATOR

A CTQ Coordinator will coordinate the delivery of smoking related care.

Other: Coordinated Care

Interventions

Coordinated Care OTHER

CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.

Also known as: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention, Nicotine Replacement, Buproprion, Wellbutrin, Chantix, Varenicline, Behavorial therapy

Coordinated Care

Usual Care OTHER

Standard therapy to help participants with smoking cessation.

Also known as: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention, Nicotine Replacement, Buproprion, Wellbutrin, Chantix, Varenicline, Behavorial therapy

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years or older
• Veterans seen by a primary care physician within the VAPHS
• Household income not more than $36,000 annually
• Smoke at least 1 cigarette per day

You may not qualify if:

• Smokeless tobacco (snuff or chew) users
• Non-cigarette (e.g., pipe) smokers
• Non-English speaking patients
• Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Cigarette Smoking; Tobacco Smoking; Tobacco Use Disorder

Interventions

Smoking Devices; Tobacco Products; Methods; Nicotine Replacement Therapy; Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; Investigative Techniques; Drug Therapy; Therapeutics; Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Hilary A. Tindle
• Organization: Vanderbilt University

hilary.tindle@vanderbilt.edu

615-875-9726

Study Officials

• Hilary A. Tindle, MD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 27, 2011
• First Posted: February 18, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 22, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)