Clinical trial NCT04524533: VR Smoking Cessation During a Dental Hygiene Visit
Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: video-based smoking cessation
smoking cessation evidence-based treatments (EBTs)
text messages
dental cleaning
smoking cessation
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-08-24
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment.

Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group

Detailed description: Approximately 400 patients who have a scheduled prophylaxis, root planing and scaling dental appointment at the BUGSDM patient treatment center will be recruited and enrolled in the randomized controlled trial. Participants who complete the baseline survey will be randomized to either the intervention or control group. The intervention group will watch one of two smoking cessation videos during the appointment (depending on readiness to quit), receive a brochure about EBTs for smoking cessation, and participate in a 4-week tailored text message program designed to motivate EBT utilization. After the 4-week text message program, the intervention group will receive monthly assessment text messages for six months. The control group will watch a control video during the appointment, receive the same brochure about EBTs as the intervention group, and participate in an assessment-only 4-week text message program. All videos are approximately 10 minutes long.

After the dental clinic appointment, all participants will complete an online questionnaire and begin the 4-week text message program.

At the end of the 4-week text message program, and 3 and 6 months later, all participants will complete online questionnaires.

Primary Aim 1: To test the efficacy of the intervention vs. control in increasing utilization of EBTs over the course of follow-up (7-months). Hypothesis 1.1: Smokers randomized to the intervention will be more likely to engage with (contact) EBTs. Hypothesis 1.2: Smokers randomized to the intervention will have greater treatment utilization (e.g., more days in the text message program, more days using smoking cessation medication, and more quitline counseling sessions, greater number of EBTs).

Secondary Aims:

Aim 2: To test the effect of the intervention vs. controls on quit attempts and on motivation to quit. Hypothesis 2: Smokers randomized to the intervention will have more quit attempts and higher motivation to quit.

Aim 3: To test the efficacy of the intervention vs controls on biochemically verified abstinence. Hypothesis 3: Smokers randomized to the intervention will have higher quit rates at follow-up.

Aim 4: To assess the mechanisms through which the intervention effects occur (social cognitive mediators) and to identify subpopulations for whom intervention effects differ (moderators, e.g., readiness to quit, gender, race/ethnicity). Hypothesis 4: The intervention will directly affect the putative mediators, which will in turn affect EBT utilization. The role of moderators will be exploratory.

Eligibility criteria: Inclusion Criteria:

* Patient of the Boston University, Henry M Goldman School of Dental Medicine treatment center with an upcoming dental hygiene appointment (dental prophylaxis or scaling and root planing)
* Self-reported smoking 100 cigarettes or more (not including e-cigarettes or vaping) in lifetime
* Self-reported smoking any cigarette (not including e-cigarettes or vaping) in the preceding week
* Self-reported cigarettes (not including e-cigarettes or vaping) 'some days', 'most days' or 'every day' in the preceding week
* Is able to understand written and spoken study materials
* Score of 'Never,' 'Rarely' or 'Sometimes' on the validated single-item literacy screener ("How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor, dentist, or pharmacy?")
* Self-reported visual capacity to watch a video as indicated by the score 'Some difficulty' or 'No difficulty' to: "How much difficulty do you have with your vision, even when wearing glasses?"
* Self-reported ability to wear headphones that are inserted partially inside the ear
* Self-reported use of text messaging at least once in the preceding month
* Self-reported access to necessary resources for intervention: Cell phone capable of text messaging
* Live in Massachusetts
* Stated willingness to comply with text message program procedures (receive and respond to text messages for 4-weeks)

Exclusion Criteria:

* Participation in another treatment or intervention study for smoking cessation or research involving text messaging
* Current use of medications for smoking cessation or smoking reduction (nicotine replacement product, or non-nicotine medications) whether prescribed or not
* Failure to complete the pre-dental clinic appointment procedure before the start of the dental appointment (opt-into the text message program and complete the baseline questionnaire)
* Failure to show up to scheduled dental appointment at the clinic
* Previous participation in the pilot phase
* Could not watch video during dental appointment

Primary outcomes:
measure: Utilization of Massachusetts State Quitline
timeFrame: 7 months
measure: Utilization of the National Cancer Institute "SmokefreeTXT" service
timeFrame: 7 months
measure: Utilization of clinic or hospital-based smoking cessation services
timeFrame: 7 months
Secondary outcomes:
measure: Use of a combination of EBTs
timeFrame: 7 months
measure: Quit smoking attempts
timeFrame: 7 months
measure: Motivation to quit smoking
timeFrame: 7 months
measure: 7-day point prevalence smoking abstinence at end-of-treatment
timeFrame: 1 month
measure: 7-day point prevalence smoking abstinence at end-of-treatment
timeFrame: 3 months
measure: 7-day point prevalence smoking abstinence at end-of-treatment
timeFrame: 6 months
measure: Participant's satisfaction
timeFrame: within 10 days after the dental clinic visit.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Henry M Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Henry M Goldman School of Dental Medicine
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borrelli B, Endrighi R, Jurasic MM, Hernandez H, Jones E, Ospina J, Cabral HJ, Quintiliani LM, Werntz S. A smoking cessation induction intervention via virtual reality headset during a dental cleaning: protocol for a randomized controlled trial. BMC Public Health. 2022 May 31;22(1):1074. doi: 10.1186/s12889-022-13427-y.