Trial Outcomes & Findings for Usability Study of a Smoking Cessation Intervention During a Dental Cleaning (NCT NCT04247061)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-05-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Could not attend dental clinic visit due to state mandated closure due to Covid-19 pandemic	6
Overall Study Subjects canceled their dental hygiene appt. (& thus the research visit) due to Covid-19 concerns	2
Overall Study Participant indicated inability to wear VR headset at dental appt.	1

Baseline Characteristics

Usability Study of a Smoking Cessation Intervention During a Dental Cleaning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smoking Cessation Intervention n=16 Participants 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.
Age, Continuous	44.6 years STANDARD_DEVIATION 12.2 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Region of Enrollment United States	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=4 Participants 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.
Feasibility of the Smoking Cessation Education Program	4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=4 Participants 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.
Participant Acceptability Rate of the Program	5.9 Units on a scale (1 to 7 scale) Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=4 Participants 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.
Participant Satisfaction With the Program	4.5 units on a scale (1 to 5 scale) Standard Deviation 0.58

SECONDARY outcome

Timeframe: 6 weeks

The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking.

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=4 Participants 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.
Attitudes About Smoking	4 Participants

SECONDARY outcome

Timeframe: 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.

An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=3 Participants 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.
The Number of Participants With Quit Attempts Lasting ≥ 24 Hours	3 Participants

SECONDARY outcome

Timeframe: 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)

An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking

Outcome measures

Outcome measures
Measure	Smoking Cessation Intervention n=3 Participants 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.
Methods for Quitting Smoking Acupuncture or hypnosis	1 Participants
Methods for Quitting Smoking Cold turkey (without aid)	3 Participants
Methods for Quitting Smoking Brochure or book	1 Participants
Methods for Quitting Smoking Gradually cutting back cigarettes	2 Participants
Methods for Quitting Smoking Nicotine replacement patch	1 Participants
Methods for Quitting Smoking Quit smoking mobile apps	1 Participants
Methods for Quitting Smoking Quit smoking text message program (other than VR study text message)	2 Participants
Methods for Quitting Smoking Quit smoking online program	1 Participants
Methods for Quitting Smoking Watched a video on how to stop smoking (other than video watched at dental visit)	2 Participants

Adverse Events

Smoking Cessation Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Center for Behavioral Science Research

Boston University

Phone: 6173583358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place