跳至主要内容
临床试验/NCT02347124
NCT02347124已完成不适用

Promoting Oral Health Among Tobacco Quitline Callers

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 718 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
718
试验地点
2
主要终点
7 Day Point Prevalent Abstinence (PPA)

研究概览

简要总结

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

  1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].
  2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome].
  3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

详细描述

Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.

Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Usual Care Control

Active Comparator

Standard tobacco quitline counseling program and materials + attention-matched text messaging.

干预措施: Usual Care Control (Behavioral)

Enhanced Intervention

Experimental

Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .

干预措施: Enhanced Intervention (Behavioral)

结局指标

主要结局

7 Day Point Prevalent Abstinence (PPA)

时间窗: 6 month post-enrollment

7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

Professional Dental Care Utilization in Past 6 Months

时间窗: 6 months post-enrollment

self-reported utilization of professional dental care during study observation period

次要结局

  • 7 Day Point Prevalent Abstinence (PPA)(2 months post-enrollment)
  • 7 Day Point Prevalent Smoking Abstinence (PPA)(6 months post-enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验