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Tobacco Dependence Treatment Education for Dental Students

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ClinicalTrials.gov Identifier: NCT01522924
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : August 22, 2013
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Jacqueline A. Singleton, University of Louisville

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Smoking
Intervention: Other: Counseling practice sessions

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 42   52   94 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      42 100.0%      52 100.0%      94 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.66  (4.31)   25.00  (3.74)   25.29  (3.99) 
Sex/Gender, Customized [1] 
[Units: Participants]
     
Female   12   23   35 
Male   29   29   58 
[1] Missing data on one participant. Data is unknown.
Region of Enrollment 
[Units: Participants]
     
United States   42   52   94 


  Outcome Measures

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) ]

Measure Type Primary
Measure Title Change From Baseline in Attitude Score
Measure Description The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) "It is important for members of the profession to discuss tobacco use with patients" and 2.) "A brief intervention (3 minutes) for tobacco cessation with my patients would be effective." The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2.
Time Frame Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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.
The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.

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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Attitude Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 .64  (2.61)   -.25  (2.27) 

No statistical analysis provided for Change From Baseline in Attitude Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Perceived Barriers Score
Measure Description The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.
Time Frame Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)  

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.
The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.

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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Perceived Barriers Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.83  (1.53)   .87  (1.78) 

No statistical analysis provided for Change From Baseline in Perceived Barriers Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Subjective Norms Score
Measure Description Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.
Time Frame Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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.
The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.

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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Subjective Norms Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.55  (4.73)   .67  (3.42) 

No statistical analysis provided for Change From Baseline in Subjective Norms Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Perceived Skills Score
Measure Description The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.
Time Frame Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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
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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Perceived Skills Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.52  (6.62)   3.38  (4.84) 

No statistical analysis provided for Change From Baseline in Perceived Skills Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Self-efficacy Score
Measure Description Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.
Time Frame Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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
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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Self-efficacy Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.34  (8.61)   7.66  (6.90) 

No statistical analysis provided for Change From Baseline in Self-efficacy Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Intentions Score
Measure Description Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.
Time Frame Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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
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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Intentions Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.88  (9.05)   1.90  (6.96) 

No statistical analysis provided for Change From Baseline in Intentions Score



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) ]

Measure Type Primary
Measure Title Change From Baseline in Tobacco Cessation Knowledge Score
Measure Description The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.
Time Frame Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)  

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
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

Measured Values
   Counseling Practice Sessions   Lecture Only 
Participants Analyzed 
[Units: Participants]
 42   52 
Change From Baseline in Tobacco Cessation Knowledge Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.55  (2.98)   2.60  (2.77) 

No statistical analysis provided for Change From Baseline in Tobacco Cessation Knowledge Score




  Serious Adverse Events


  Other Adverse Events


  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
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

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: Jacqueline A. Singleton, University of Louisville
ClinicalTrials.gov Identifier: NCT01522924     History of Changes
Other Study ID Numbers: 12.0026
First Submitted: January 24, 2012
First Posted: February 1, 2012
Results First Submitted: January 7, 2013
Results First Posted: August 22, 2013
Last Update Posted: May 23, 2017