- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01522924
Tobacco Dependence Treatment Education for Dental Students
2017년 4월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
94
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kentucky
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Louisville, Kentucky, 미국, 40292
- University of Louisville School of Dentistry
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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간섭 없음: Lecture only
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Attitude Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jacqueline A Singleton, MEd, University of Louisville
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 2월 1일
기본 완료 (실제)
2012년 4월 1일
연구 완료 (실제)
2012년 4월 1일
연구 등록 날짜
최초 제출
2012년 1월 24일
QC 기준을 충족하는 최초 제출
2012년 1월 27일
처음 게시됨 (추정)
2012년 2월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 12일
마지막으로 확인됨
2017년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12.0026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .