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Connect to Quit for Smoking (CTQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01299896
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : February 24, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Smoking
Smoking Cessation
Interventions: Other: Coordinated Care
Other: Usual Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Usual Care

Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (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.

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

Coordinated Care

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

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.


Participant Flow:   Overall Study
    Usual Care   Coordinated Care
STARTED   319   314 
COMPLETED   318   296 
NOT COMPLETED   1   18 
Withdrawal by Subject                1                7 
Lost to Follow-up                0                11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care

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.

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

Coordinated Care

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

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.

Total Total of all reporting groups

Baseline Measures
   Usual Care   Coordinated Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 319   314   633 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.7  (11.5)   55.7  (8.7)   55.2  (10.2) 
Gender 
[Units: Participants]
     
Female   28   38   66 
Male   291   276   567 
Region of Enrollment 
[Units: Participants]
     
United States   319   314   633 


  Outcome Measures

1.  Primary:   Effectiveness of CTQ vs UC   [ Time Frame: Two (2) year period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Hilary A. Tindle
Organization: Vanderbilt University
phone: 615-875-9726
e-mail: hilary.tindle@vanderbilt.edu



Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01299896     History of Changes
Other Study ID Numbers: 02936
R01CA141596 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2011
First Posted: February 18, 2011
Results First Submitted: January 21, 2016
Results First Posted: February 24, 2016
Last Update Posted: March 22, 2016