Promoting Oral Health Among Smokers Randomized Trial

Smoking Clinical Trial

Official title:

Promoting Oral Health Among Tobacco Quitline Callers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347124
• Other study ID #: 14-047-E
• Secondary ID: U01DE024462-01
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 718
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Disease
• Smoking

Intervention

Behavioral:
• Usual Care Control
Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
• Enhanced Intervention
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)

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Alere Wellbeing, National Institute of Dental and Craniofacial Research (NIDCR), University of California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up	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
Other	Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up	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
Other	Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up	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
Other	Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up	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
Other	Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up	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
Other	Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up	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
Other	Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up	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
Other	Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up	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
Other	Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up	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
Other	Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up	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
Primary	7 Day Point Prevalent Abstinence (PPA)	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
Primary	Professional Dental Care Utilization in Past 6 Months	self-reported utilization of professional dental care during study observation period	6 months post-enrollment
Secondary	7 Day Point Prevalent Abstinence (PPA)	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
Secondary	7 Day Point Prevalent Smoking Abstinence (PPA)	Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.	2 months post-enrollment
Secondary	7 Day Point Prevalent Smoking Abstinence (PPA)	Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.	6 months post-enrollment