Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Message Framing for Telephone Quitline Callers

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
  Hide 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
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
  Hide 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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


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 ( Other Grant/Funding Number: NCI R21 CA127818 )
Study First Received: January 3, 2008
Results First Received: January 2, 2013
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board