Usability Study of a Smoking Cessation Intervention During a Dental Cleaning

NCT04247061 | Terminated Results

• 2 other identifiers: H-390531UG3DE028866
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this usability study is to pilot test the recruitment procedures, data acquisition methods, and text message program integration required to support the planning of a future clinical trial. Approximately 15 smokers who are patients of the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center and have an upcoming dental prophylaxis or scaling and root planing (henceforth referred to as 'teeth cleaning') appointment will be recruited. During the dental cleaning, participants will watch a brief educational video that provides guidance and advice on smoking cessation. At the end of the dental appointment, participants will complete a survey about their experience watching the video and their attitudes towards smoking cessation. Participants will also receive other smoking cessation resources with instructions on how to access the services. Participants will then use the one-month text message program developed by the investigators to motivate and facilitate contact with the smoking cessation resources. At the end of the one-month text message program, participants will complete a survey about their experience during the text message program, their smoking habits, and attitudes towards smoking cessation. The duration of the study will be approximately six-weeks.

Conditions

Smoking, Cessation

Keywords

Dental cleaning; Video; Text messages

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Smoking Cessation Education Program

  The number of participants who watched the video and used the text messaging for a month.

  6 weeks

• Participant Acceptability Rate of the Program

  Participants were asked to rate the acceptability of the program by answering an investigator developed acceptability question with a scale of 1 to 7, where 1= the program was not acceptable and 7= the program was very acceptable. Scores could range from 1 to 7, and higher scores are associated with greater acceptability of the program.

  6 weeks

• Participant Satisfaction With the Program

  Participants were asked to rate their satisfaction of the program by answering an investigator developed satisfaction question with a scale of 1 to 5, where 1= they were not satisfied with the program and 5= they were very satisfied with the program. Higher scores were associated with greater satisfaction with the program.

  6 weeks

Secondary Outcomes (4)

• Attitudes About Smoking

  6 weeks

• Change in Number of Cigarettes Smoked Per Day

  Baseline, 6 weeks

• The Number of Participants With Quit Attempts Lasting ≥ 24 Hours

  6 weeks

• Methods for Quitting Smoking

  6 weeks

Study Arms (1)

Smoking Cessation intervention

EXPERIMENTAL

At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.

Other: Educational video; Other: Text-message program

Interventions

Educational video OTHER

One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs

Smoking Cessation intervention

Text-message program OTHER

A one-month text message program to motivate and facilitate contact with smoking cessation resources.

Smoking Cessation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a patient of the Boston University, Henry M Goldman School of Dental Medicine patient treatment center
• Must have smoked 100 cigarettes or more (not e-cigarettes or vaping) in lifetime
• Must have smoked cigarettes (not e-cigarettes or vaping) 'most days' or 'every day' in the past week
• Must read and write fluently in English
• Must be willing to watch a video during the dental hygiene appointment
• Must have the visual capacity to watch a video
• Ability to wear in-ear headphones
• Must have a mobile phone capable of receiving and sending text messages (SMS)
• live in Greater Boston area for the next two months
• Have a cell phone carrier that can receive text message from our system

You may not qualify if:

• Planning to move out of the Greater Boston area within the next two months

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Of the 16 enrolled subjects, n=13 completed required pre-dental visit activities \& were scheduled to attend the clinic. Of the 13, n=4 completed the study (n=6 could not attend clinic due to Covid-19, state-mandated closure; n=2 canceled their dental appointment due to Covid-19 concerns; n=1 indicated inability to wear VR headset at the clinic). Thus, due to the Covid-19 pandemic restrictions, this usability study was terminated early leading to small numbers of subjects completing the study.

Results Point of Contact

• Title: Director of Center for Behavioral Science Research
• Organization: Boston University

belindab@bu.edu

6173583358

Study Officials

• Belinda Borrelli, PhD

  Henry M Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 29, 2020
• Study Start: February 4, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)