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'Questions About Quitting' Smoking Cessation Trial (Q2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992264
First Posted: October 9, 2009
Last Update Posted: October 13, 2017
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.
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Kaiser Permanente
Results First Submitted: April 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Smoking
Interventions: Behavioral: Message Tone
Behavioral: Navigation
Behavioral: Proactive Outreach
Behavioral: Testimonials

  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
Participants were recruited from Group Health, a large, non-profit health plan in the US Pacific Northwest. Data were collected between May 2010 and November 2012. All intervention and data collection occurred online.

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
Randomization Arm 1 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
Randomization Arm 2 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
Randomization Arm 3 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
Randomization Arm 4 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
Randomization Arm 5 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
Randomization Arm 6 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
Randomization Arm 7 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
Randomization Arm 8 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
Randomization Arm 9 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
Randomization Arm 10 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
Randomization Arm 11 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
Randomization Arm 12 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
Randomization Arm 13 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
Randomization Arm 14 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
Randomization Arm 15 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
Randomization Arm 16 Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]

Participant Flow:   Overall Study
    Randomization Arm 1   Randomization Arm 2   Randomization Arm 3   Randomization Arm 4   Randomization Arm 5   Randomization Arm 6   Randomization Arm 7   Randomization Arm 8   Randomization Arm 9   Randomization Arm 10   Randomization Arm 11   Randomization Arm 12   Randomization Arm 13   Randomization Arm 14   Randomization Arm 15   Randomization Arm 16
STARTED   116   116   117   117   117   117   116   117   116   116   117   117   116   117   117   116 
COMPLETED   116 [1]   116 [1]   117 [1]   117 [1]   117 [1]   117 [1]   116 [1]   117 [1]   116 [1]   116 [1]   117 [1]   117 [1]   116 [1]   117 [1]   117 [1]   116 [1] 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 
[1] All enrolled participants were included in the final intent to treat analytic sample.



  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.
1865 participants were enrolled and randomized. For the analyses, participants assigned to each contrasting level of each of the 4 experimental factors were compared against one another. Thus, 1865 people were in each analytic arm in this factorial screening experiment.

Reporting Groups
  Description
Randomization Arm: 1 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
Radndomization Arm: 2 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
Randomization Arm: 3 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
Randomization Arm: 4 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
Randomization Arm: 5 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
Randomization Arm: 6 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
Randomization Arm: 7 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
Randomization Arm: 8 Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
Randomization Arm: 9 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
Randomization Arm: 10 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
Randomization Arm: 11 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
Randomization Arm: 12 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
Randomization Arm: 13 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
Randomization Arm: 14 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
Randomization Arm: 15 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
Randomization Arm: 16 Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
Total Total of all reporting groups

Baseline Measures
   Randomization Arm: 1   Radndomization Arm: 2   Randomization Arm: 3   Randomization Arm: 4   Randomization Arm: 5   Randomization Arm: 6   Randomization Arm: 7   Randomization Arm: 8   Randomization Arm: 9   Randomization Arm: 10   Randomization Arm: 11   Randomization Arm: 12   Randomization Arm: 13   Randomization Arm: 14   Randomization Arm: 15   Randomization Arm: 16   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   116   117   117   117   117   116   117   116   116   117   117   116   117   117   116   1865 
Age 
[Units: Participants]
Count of Participants
                                 
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      111  95.7%      108  93.1%      110  94.0%      111  94.9%      110  94.0%      111  94.9%      108  93.1%      108  92.3%      108  93.1%      112  96.6%      109  93.2%      111  94.9%      114  98.3%      113  96.6%      110  94.0%      109  94.0%      1763  94.5% 
>=65 years      5   4.3%      8   6.9%      7   6.0%      6   5.1%      7   6.0%      6   5.1%      8   6.9%      9   7.7%      8   6.9%      4   3.4%      8   6.8%      6   5.1%      2   1.7%      4   3.4%      7   6.0%      7   6.0%      102   5.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.34  (14.50)   44.06  (14.95)   42.83  (15.06)   45.93  (13.82)   43.49  (14.34)   43.84  (14.39)   45.19  (14.6)   44.33  (15.05)   44.56  (15.43)   43.82  (14.24)   46.09  (14.75)   45.03  (14.26)   42.29  (15.07)   43.69  (14.95)   44.39  (14.95)   43.99  (14.97)   44.2  (14.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                                 
Female      75  64.7%      79  68.1%      76  65.0%      66  56.4%      39  33.3%      76  65.0%      73  62.9%      69  59.0%      74  63.8%      77  66.4%      72  61.5%      76  65.0%      65  56.0%      69  59.0%      76  65.0%      77  66.4%      1139  61.1% 
Male      41  35.3%      37  31.9%      41  35.0%      51  43.6%      78  66.7%      41  35.0%      43  37.1%      48  41.0%      42  36.2%      39  33.6%      45  38.5%      41  35.0%      51  44.0%      48  41.0%      41  35.0%      39  33.6%      726  38.9% 
Region of Enrollment 
[Units: Participants]
                                 
United States   116   116   117   117   117   117   116   117   116   116   117   117   116   117   117   116   1865 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Smoking Abstinence   [ Time Frame: 12 months ]

2.  Primary:   Treatment Utilization for Smoking Cessation   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study was powered to detect differences between each factor level of 5% or more.


  More Information
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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: Jennifer McClure
Organization: Group Health Research Institute
phone: 206-287-2737
e-mail: mcclure.j@ghc.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00992264     History of Changes
Other Study ID Numbers: R01CA138598 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2009
First Posted: October 9, 2009
Results First Submitted: April 4, 2014
Results First Posted: August 15, 2014
Last Update Posted: October 13, 2017