'Questions About Quitting' Smoking Cessation Trial (Q2)

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00992264
First received: October 7, 2009
Last updated: August 21, 2014
Last verified: August 2014
Results First Received: April 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   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
N/A

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  
Number of Participants  
[units: participants]
  116     116     117     117     117     117     116     117     116     116     117     117     116     117     117     116     1865  
Age  
[units: participants]
                                 
<=18 years     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0  
Between 18 and 65 years     111     108     110     111     110     111     108     108     108     112     109     111     114     113     110     109     1763  
>=65 years     5     8     7     6     7     6     8     9     8     4     8     6     2     4     7     7     102  
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  
Gender  
[units: participants]
                                 
Female     75     79     76     66     39     76     73     69     74     77     72     76     65     69     76     77     1139  
Male     41     37     41     51     78     41     43     48     42     39     45     41     51     48     41     39     726  
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:

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00992264     History of Changes
Other Study ID Numbers: R01CA138598
Study First Received: October 7, 2009
Results First Received: April 4, 2014
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board