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Promoting Oral Health Among Smokers Randomized Trial

26 september 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

718

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98101
        • Kaiser Permanente Washington Health Research Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Usual Care Control
Standard tobacco quitline counseling program and materials + attention-matched text messaging.
Gedragsmatig: 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.
Experimenteel: Enhanced Intervention
Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .
Gedragsmatig: 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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
7 Day Point Prevalent Abstinence (PPA)
Tijdsspanne: 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
Tijdsspanne: 6 months post-enrollment
self-reported utilization of professional dental care during study observation period
6 months post-enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
7 Day Point Prevalent Abstinence (PPA)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 6 months post-enrollment
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.
6 months post-enrollment

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kaiser Permanente

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Jennifer McClure, PhD, Kaiser Permanente

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2015

Primaire voltooiing (Werkelijk)

1 maart 2017

Studie voltooiing (Werkelijk)

1 maart 2017

Studieregistratiedata

Eerst ingediend

12 januari 2015

Eerst ingediend dat voldeed aan de QC-criteria

21 januari 2015

Eerst geplaatst (Schatting)

27 januari 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

26 september 2019

Laatst geverifieerd

1 september 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 14-047-E
  • U01DE024462-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

We do not plan to share individual level data.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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