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Tobacco Dependence Treatment Education for Dental Students

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01522924
First received: January 24, 2012
Last updated: August 19, 2013
Last verified: August 2013
Results First Received: January 7, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Smoking
Intervention: Other: Counseling practice sessions

  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
The recruitment period began on February 23 and ended on April 19. The location of the study was at a dental school and the standardized patient clinic in the medical school.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Students were excluded from the study if they did not meet study requirements.

Reporting Groups
  Description
Counseling Practice Sessions Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
Lecture Only Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture

Participant Flow:   Overall Study
    Counseling Practice Sessions     Lecture Only  
STARTED     42 [1]   52 [2]
COMPLETED     42 [3]   52 [4]
NOT COMPLETED     0     0  
[1] There were 42 dental students in the intervention group.
[2] There were 52 dental students in the control group.
[3] There were 42 dental students who completed the second survey after the intervention.
[4] There were 52 dental students who completed the second survey after the lecture.



  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.
There were 94 dental students who provided linkable surveys. There were 42 in the intervention group and 52 in the control group.

Reporting Groups
  Description
Counseling Practice Sessions Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
Lecture Only Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Total Total of all reporting groups

Baseline Measures
    Counseling Practice Sessions     Lecture Only     Total  
Number of Participants  
[units: participants]
  42     52     94  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     52     94  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.66  ± 4.31     25.00  ± 3.74     25.29  ± 3.99  
Gender, Customized [1]
[units: participants]
     
Female     12     23     35  
Male     29     29     58  
Region of Enrollment  
[units: participants]
     
United States     42     52     94  
[1] Missing data on one participant. Data is unknown.



  Outcome Measures
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1.  Primary:   Change From Baseline in Attitude Score   [ Time Frame: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]

2.  Primary:   Change From Baseline in Perceived Barriers Score   [ Time Frame: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions) ]

3.  Primary:   Change From Baseline in Subjective Norms Score   [ Time Frame: Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]

4.  Primary:   Change From Baseline in Perceived Skills Score   [ Time Frame: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]

5.  Primary:   Change From Baseline in Self-efficacy Score   [ Time Frame: Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]

6.  Primary:   Change From Baseline in Intentions Score   [ Time Frame: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]

7.  Primary:   Change From Baseline in Tobacco Cessation Knowledge Score   [ Time Frame: Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions) ]


  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
One participant in the intervention group did not provide gender information. The total number of participants in the intervention group did not equal the number of male and female participants.


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


Results Point of Contact:  
Name/Title: Dr. Jacqueline Singleton
Organization: University of Louisville
phone: 502-852-2611
e-mail: jasing02@louisville.edu


Publications of Results:

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01522924     History of Changes
Other Study ID Numbers: 12.0026
Study First Received: January 24, 2012
Results First Received: January 7, 2013
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board