- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01522924
Tobacco Dependence Treatment Education for Dental Students
12. dubna 2017 aktualizováno: Jacqueline A. Singleton, University of Louisville
Tobacco Dependence Treatment Education for Dental Students Using Standardized Patients
This study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized patients and those students receiving only a tobacco cessation lecture.
The study determines if dental students' use of tobacco affects their intent to provide cessation treatment to patients, and if the time between receiving the lecture and participating in the practice sessions using standardized patients makes a difference in dental students' attitudes, perceived barriers, subjective norms.
perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.
Přehled studie
Detailní popis
The experimental study has a pretest-posttest design.
It evaluates the changes to dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and tobacco cessation knowledge between those students receiving a lecture along with practice sessions using standardized patients and those students receiving only a lecture.
Dental students will be invited to complete two questionnaires.
The control group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture.
The experimental group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture and the practice and debriefing sessions.
Subjects will include 120 first year dental students in an introductory course to clinical dentistry.
The cessation training is a required activity in the course.
Students are divided into small groups according to their bench or lab numbers.
These numbers are assigned to the student based on the alphabetical order of their name.
The eligibility criteria is: 1) Must be a first year dental student in Introduction to Clinical Dentistry 1 at the University of Louisville, and 2) Must be willing to volunteer to complete pre- and post-questionnaires about the cessation treatment educational program.
The exclusion criteria is: Subject is not willing to give consent to complete the pre- and post- questionnaire.
Typ studie
Intervenční
Zápis (Aktuální)
94
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kentucky
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Louisville, Kentucky, Spojené státy, 40292
- University of Louisville School of Dentistry
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- must be a first year dental student in Introduction to Clinical Dentistry I at the study institution
- volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training.
Exclusion Criteria:
- subject does not complete pre- and post- questionnaires.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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Dental students will complete the first questionnaire before a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients and a debriefing session.
Ostatní jména:
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Žádný zásah: Lecture only
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in Attitude Score
Časové okno: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Change From Baseline in Perceived Barriers Score
Časové okno: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
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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.
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Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
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Change From Baseline in Subjective Norms Score
Časové okno: Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Change From Baseline in Perceived Skills Score
Časové okno: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Change From Baseline in Self-efficacy Score
Časové okno: Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Change From Baseline in Intentions Score
Časové okno: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Change From Baseline in Tobacco Cessation Knowledge Score
Časové okno: Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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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.
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Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jacqueline A Singleton, MEd, University of Louisville
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2012
Primární dokončení (Aktuální)
1. dubna 2012
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
24. ledna 2012
První předloženo, které splnilo kritéria kontroly kvality
27. ledna 2012
První zveřejněno (Odhad)
1. února 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. května 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. dubna 2017
Naposledy ověřeno
1. dubna 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12.0026
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