Promoting Oral Health Among Smokers Randomized Trial
Promoting Oral Health Among Tobacco Quitline Callers
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:
- 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].
- Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome].
- Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Washington
-
Seattle, Washington, 미국, 98101
- Kaiser Permanente Washington Health Research Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Male or female, aged 18 or older
- Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
- Can read and speak in English
- Current daily smoker and smokes at least 5 cigarettes a day
- Interested in quitting smoking in next 30 days
- Have some or all natural teeth
- Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
- Has a cell phone capable of receiving text messages and provides cell phone number
- Has internet access for personal use
- Willing to talk about ways to improve their oral health
- Provides verbal consent to participate
Exclusion criteria:
- Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
- Have lived at the current address less than 6 months or plans to move in the next 6 months
- Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
- Has a household member already enrolled in the study, based on self-report and/or mailing address on file
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Usual Care Control
Standard tobacco quitline counseling program and materials + attention-matched text messaging.
|
Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
|
|
실험적: Enhanced Intervention
Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .
|
Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
7 Day Point Prevalent Abstinence (PPA)
기간: 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.
|
6 month post-enrollment
|
|
Professional Dental Care Utilization in Past 6 Months
기간: 6 months post-enrollment
|
self-reported utilization of professional dental care during study observation period
|
6 months post-enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
7 Day Point Prevalent Abstinence (PPA)
기간: 2 months post-enrollment
|
7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers
|
2 months post-enrollment
|
|
7 Day Point Prevalent Smoking Abstinence (PPA)
기간: 2 months post-enrollment
|
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only.
No outcomes imputed.
|
2 months post-enrollment
|
|
7 Day Point Prevalent Smoking Abstinence (PPA)
기간: 6 months post-enrollment
|
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis.
No outcomes imputed.
|
6 months post-enrollment
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
기간: Baseline to 2 months
|
Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale: Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals. Responses and scoring to the adapted NHIS scale: Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5 Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge. The scores have a range of 7 (minimum) to 35 (maximum). The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge. |
Baseline to 2 months
|
|
Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up
기간: Baseline to 6 months
|
Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale: Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals. Responses and scoring to the adapted NHIS scale: Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5 Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge. The scores have a range of 7 (minimum) to 35 (maximum). The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge. |
Baseline to 6 months
|
|
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up
기간: Baseline to 2 months
|
SE to see a dentist was assessed using the following question: "As of today, how confident are you that you can…See a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy. |
Baseline to 2 months
|
|
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up
기간: Baseline to 6 months
|
SE to see a dentist was assessed using the following question: "As of today, how confident are you that you can…See a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy. |
Baseline to 6 months
|
|
Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up
기간: Baseline to 2 months
|
Motivation to stop smoking was assessed using the following question: "As of today, how motivated are you to…Stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation. |
Baseline to 2 months
|
|
Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up
기간: Baseline to 6 months
|
Motivation to stop smoking was assessed using the following question: "As of today, how motivated are you to…Stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation. |
Baseline to 6 months
|
|
Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up
기간: Baseline to 2 months
|
Motivation to see a dentist was assessed using the following question: "As of today, how motivated are you to…see a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation. |
Baseline to 2 months
|
|
Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up
기간: Baseline to 6 months
|
Motivation to see a dentist was assessed using the following question: "As of today, how motivated are you to…see a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation. |
Baseline to 6 months
|
|
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up
기간: Baseline to 2 months
|
SE to quit smoking was assessed using the following question: "As of today, how confident are you that you can…stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy. |
Baseline to 2 months
|
|
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up
기간: Baseline to 6 months
|
SE to quit smoking was assessed using the following question: "As of today, how confident are you that you can…stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy. |
Baseline to 6 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jennifer McClure, PhD, Kaiser Permanente
간행물 및 유용한 링크
일반 간행물
- Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
- McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available.
- McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12. Erratum In: Contemp Clin Trials. 2017 Oct;61:133.
- Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .