Message Framing for Telephone Quitline Callers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University
ClinicalTrials.gov Identifier:
NCT00589277
First received: January 3, 2008
Last updated: January 2, 2013
Last verified: January 2013
Results First Received: January 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Smoking
Nicotine Dependence
Interventions: Behavioral: "Yale coaching"
Behavioral: Standard care

  Participant Flow
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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
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Reporting Groups
  Description
Standard Care Counseling Standard care counseling + standard care print information
Gain-Framed Counseling Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.

Participant Flow:   Overall Study
    Standard Care Counseling     Gain-Framed Counseling  
STARTED     1222     810  
Completed 2 Week Follow Up     603     424  
Completed 3 Month Follow Up     762     524  
COMPLETED     762     524  
NOT COMPLETED     460     286  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Standard Care Counseling Standard care counseling + standard care print information
Gain-Framed Counseling Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
Total Total of all reporting groups

Baseline Measures
    Standard Care Counseling     Gain-Framed Counseling     Total  
Number of Participants  
[units: participants]
  1222     810     2032  
Age  
[units: years]
Mean ± Standard Deviation
  46.4  ± 13.9     47.2  ± 13.4     46.5  ± 13.7  
Gender  
[units: participants]
     
Female     675     478     1153  
Male     547     332     879  



  Outcome Measures
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1.  Primary:   Quit Attempt   [ Time Frame: 2 week follow up ]

2.  Secondary:   24 Hour Abstinence   [ Time Frame: 2 week follow up ]

3.  Secondary:   7 Day Abstinence   [ Time Frame: 3 month follow up ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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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Results Point of Contact:  
Name/Title: Benjamin Toll, Ph.D. Associate Professor of Psychiatry
Organization: Yale University School of Medicine
phone: (203) 974 5767
e-mail: benjamin.toll@yale.edu


Publications of Results:

Responsible Party: Benjamin A. Toll, Yale University
ClinicalTrials.gov Identifier: NCT00589277     History of Changes
Other Study ID Numbers: NCI R21 CA127818, 0705002661
Study First Received: January 3, 2008
Results First Received: January 2, 2013
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board