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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01299896
Other study ID # 02936
Secondary ID R01CA141596
Status Completed
Phase N/A
First received January 27, 2011
Last updated January 26, 2016
Start date March 2011
Est. completion date February 2015

Study information

Verified date January 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Coordinated Care
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.
Usual Care
Standard therapy to help participants with smoking cessation.

Locations

Country Name City State
United States VA Pittsburgh Healthcare System Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pittsburgh National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of CTQ vs UC We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate self reported abstinence (30 day point-prevalence) at the end of 2 years. Two (2) year period No
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