- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01522924
Tobacco Dependence Treatment Education for Dental Students
12. April 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
94
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40292
- University of Louisville School of Dentistry
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
Andere Namen:
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Kein Eingriff: Lecture only
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change From Baseline in Attitude Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Jacqueline A Singleton, MEd, University of Louisville
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2012
Primärer Abschluss (Tatsächlich)
1. April 2012
Studienabschluss (Tatsächlich)
1. April 2012
Studienanmeldedaten
Zuerst eingereicht
24. Januar 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. Januar 2012
Zuerst gepostet (Schätzen)
1. Februar 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. Mai 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. April 2017
Zuletzt verifiziert
1. April 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12.0026
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