Smoking, Cessation
Conditions
Keywords
Dental cleaning, Video, Text messages
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.
Interventions
OTHEREducational video
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
OTHERText-message program
A one-month text message program to motivate and facilitate contact with smoking cessation resources.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Boston University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
-Planning to move out of the Greater Boston area within the next two months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Smoking Cessation Education Program | 6 weeks | The number of participants who watched the video and used the text messaging for a month. |
| Participant Acceptability Rate of the Program | 6 weeks | 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. |
| Participant Satisfaction With the Program | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes About Smoking | 6 weeks | The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking. |
| Methods for Quitting Smoking | 6 weeks | An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking |
| Change in Number of Cigarettes Smoked Per Day | Baseline, 6 weeks | An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily |
| The Number of Participants With Quit Attempts Lasting ≥ 24 Hours | 6 weeks | The number of participants who attempted to quit smoking for 24 hours or more at follow-up because they wanted to quit (not due to hospitalization or illness) based on an investigator-developed survey that asked participants questions about the number of quit attempts lasting ≥ 24 hours |
Countries
United States
Participant flow
Pre-assignment details
16 subjects were enrolled (provided informed consent to participate). Of the 16 enrolled, 13 subjects completed the pre-dental visit activities (n=1 did not opt into the text message program, n=2 did not complete the baseline questionnaire) and were scheduled to attend the dental clinic visit.
Participants by arm
| Arm | Count |
|---|---|
| Smoking Cessation Intervention 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.
Educational video: 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
Text-message program: A one-month text message program to motivate and facilitate contact with smoking cessation resources. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Could not attend dental clinic visit due to state mandated closure due to Covid-19 pandemic | 6 |
| Overall Study | Participant indicated inability to wear VR headset at dental appt. | 1 |
| Overall Study | Subjects canceled their dental hygiene appt. (& thus the research visit) due to Covid-19 concerns | 2 |
Baseline characteristics
| Characteristic | Smoking Cessation Intervention |
|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Feasibility of the Smoking Cessation Education Program
The number of participants who watched the video and used the text messaging for a month.
Time frame: 6 weeks
Population: 16 participants provided informed consent. Of the 16, n=13 completed required pre-dental visit study activities and were scheduled to attend the clinic visit. Of the 13, n=4 completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Intervention | Feasibility of the Smoking Cessation Education Program | 4 Participants |
Primary
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.
Time frame: 6 weeks
Population: 16 participants provided informed consent. Of the 16, n=13 completed required pre-dental visit study activities and were scheduled to attend the clinic visit. Of the 13, n=4 completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Intervention | Participant Acceptability Rate of the Program | 5.9 Units on a scale (1 to 7 scale) | Standard Deviation 1.3 |
Primary
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.
Time frame: 6 weeks
Population: 16 participants provided informed consent. Of the 16, n=13 completed required pre-dental visit study activities and were scheduled to attend the clinic visit. Of the 13, n=4 completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Intervention | Participant Satisfaction With the Program | 4.5 units on a scale (1 to 5 scale) | Standard Deviation 0.58 |
Secondary
Attitudes About Smoking
The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Intervention | Attitudes About Smoking | 4 Participants |
Secondary
Change in Number of Cigarettes Smoked Per Day
An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily
Time frame: Baseline, 6 weeks
Population: The change in the number of cigarettes smoked per day between baseline and follow-up cannot be computed because the one participant who reported smoking at follow-up did not report the number of cigarettes.
Secondary
Methods for Quitting Smoking
An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking
Time frame: 6 weeks
Population: The number of participants who indicated that they used one or more methods to help them quit smoking (or help them make an attempt to quit smoking)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smoking Cessation Intervention | Methods for Quitting Smoking | Acupuncture or hypnosis | 1 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Cold turkey (without aid) | 3 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Brochure or book | 1 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Gradually cutting back cigarettes | 2 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Nicotine replacement patch | 1 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Quit smoking mobile apps | 1 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Quit smoking text message program (other than VR study text message) | 2 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Quit smoking online program | 1 Participants |
| Smoking Cessation Intervention | Methods for Quitting Smoking | Watched a video on how to stop smoking (other than video watched at dental visit) | 2 Participants |
Secondary
The Number of Participants With Quit Attempts Lasting ≥ 24 Hours
The number of participants who attempted to quit smoking for 24 hours or more at follow-up because they wanted to quit (not due to hospitalization or illness) based on an investigator-developed survey that asked participants questions about the number of quit attempts lasting ≥ 24 hours
Time frame: 6 weeks
Population: 16 participants provided informed consent. Of the 16, n=13 completed required pre-dental visit study activities and were scheduled to attend the clinic visit. Of the 13, 4 completed the study, however, quit attempts data were not collected from one participant, so there are only 3 participants for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Intervention | The Number of Participants With Quit Attempts Lasting ≥ 24 Hours | 3 Participants |