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Promoting Oral Health Among Smokers Randomized Trial

26. září 2019 aktualizováno: Kaiser Permanente

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:

  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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

718

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Washington
      • Seattle, Washington, Spojené státy, 98101
        • Kaiser Permanente Washington Health Research Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Usual Care Control
Standard tobacco quitline counseling program and materials + attention-matched text messaging.
Behaviorální: 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.
Experimentální: Enhanced Intervention
Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .
Behaviorální: 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)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
7 Day Point Prevalent Abstinence (PPA)
Časové okno: 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
Časové okno: 6 months post-enrollment
self-reported utilization of professional dental care during study observation period
6 months post-enrollment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
7 Day Point Prevalent Abstinence (PPA)
Časové okno: 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)
Časové okno: 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)
Časové okno: 6 months post-enrollment
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.
6 months post-enrollment

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Kaiser Permanente

Spolupracovníci

National Institute of Dental and Craniofacial Research (NIDCR)
Consumer Wellness Solutions
University of California

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jennifer McClure, PhD, Kaiser Permanente

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2015

Primární dokončení (Aktuální)

1. března 2017

Dokončení studie (Aktuální)

1. března 2017

Termíny zápisu do studia

První předloženo

12. ledna 2015

První předloženo, které splnilo kritéria kontroly kvality

21. ledna 2015

První zveřejněno (Odhad)

27. ledna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. září 2019

Naposledy ověřeno

1. září 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 14-047-E
  • U01DE024462-01 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

We do not plan to share individual level data.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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