Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit (ACCESSATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818207
First received: January 6, 2009
Last updated: February 29, 2012
Last verified: February 2012
Results First Received: February 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Smoking Cessation
Insurance Coverage
Interventions: Other: Full Smoking Cessation Treatment Coverage (100%)
Other: No Smoking Cessation Treatment Coverage (0%)

  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
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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
Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.

Participant Flow:   Overall Study
    Reimbursement for Smoking Cessation Therapy (SCT)     No Reimbursement for SCT  
STARTED     696     684  
COMPLETED     474     417  
NOT COMPLETED     222     267  
Adverse Event                 6                 0  
Lost to Follow-up                 160                 146  
Multiple reasons                 11                 12  
Withdrawal by Subject                 42                 104  
Death                 3                 5  



  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
Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
Total Total of all reporting groups

Baseline Measures
    Reimbursement for Smoking Cessation Therapy (SCT)     No Reimbursement for SCT     Total  
Number of Participants  
[units: participants]
  696     684     1380  
Age  
[units: Years]
Mean ± Standard Deviation
  46.5  ± 12.3     46.7  ± 12.3     46.6  ± 12.3  
Gender  
[units: Participants]
     
Female     342     347     689  
Male     354     337     691  



  Outcome Measures
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1.  Primary:   Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence   [ Time Frame: Week 26 ]

2.  Secondary:   Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco   [ Time Frame: Week 26 ]

3.  Secondary:   Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52   [ Time Frame: Week 26, Week 39, and Week 52 ]

4.  Secondary:   Percentage of Participants With 7-Day PP of Abstinence at Week 13   [ Time Frame: Week 13 ]

5.  Secondary:   Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52   [ Time Frame: Week 26 to Week 52 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818207     History of Changes
Other Study ID Numbers: A3051116
Study First Received: January 6, 2009
Results First Received: February 29, 2012
Last Updated: February 29, 2012
Health Authority: Canada: Ethics Review Committee