Smoking, CessationNCT04247061

Usability Study of a Smoking Cessation Intervention During a Dental Cleaning

A study testing Educational video and Text-message program in people with Smoking, Cessation, run by Boston University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking, Cessation
What is being tested?: Educational video and Text-message program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2020to 31 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Goldman School of Dental Medicine
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study

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
Being tested: Educational video, Text-message program
Keywords: Dental cleaning, Video, Text messages
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04247061
Study group	Role	What they receive
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. Receives: Other: Educational video; Other: Text-message program

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of the Smoking Cessation Education Program
The number of participants who watched the video and used the text messaging for a month.
Measured: 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.
Measured: 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.
Measured: 6 weeks

Secondary outcomes (4)

Attitudes About Smoking
The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking.
Measured: 6 weeks
Change in Number of Cigarettes Smoked Per Day
An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily
Measured: Baseline, 6 weeks
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
Measured: 6 weeks
Methods for Quitting Smoking
An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 202031 May 2020

First posted29 Jan 2020
Study start4 Feb 2020
Primary completion31 May 2020
Study completion31 May 2020

Why it stopped: Due to COVID-19 policies this usability pilot study was stopped after enrolling 4 participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking, CessationStudies of the same condition, open and under way.
More trials run by Boston UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04247061
Sponsor's protocol ID: H-39053
Other IDs: 1UG3DE028866
Status last verified: May 2021
First submitted: 28 Jan 2020
Last updated: 7 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking, Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study
ClinicalTrials.gov ID: NCT04247061
Acronym / sponsor ID: H-39053
Conditions: Smoking, Cessation
Keywords: Dental cleaning, Video, Text messages
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to COVID-19 policies this usability pilot study was stopped after enrolling 4 participants.
Enrolment: 16 participants (actual)
Lead sponsor: Boston UniversityUniversity, hospital or other
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Study start: 4 Feb 2020 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 29 Jan 2020 (actual)
Results: Posted 7 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Smoking Cessation intervention	Experimental	Other: Educational video, Other: Text-message programAt 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Educational videoOne 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	Other	Smoking Cessation intervention
Text-message programA one-month text message program to motivate and facilitate contact with smoking cessation resources.	Other	Smoking Cessation intervention

Primary outcome

Feasibility of the Smoking Cessation Education Program
Time frame: 6 weeks
The number of participants who watched the video and used the text messaging for a month.
Participant Acceptability Rate of the Program
Time frame: 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
Time frame: 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.

4 secondary outcomes

Attitudes About Smoking
Time frame: 6 weeks
Change in Number of Cigarettes Smoked Per Day
Time frame: Baseline, 6 weeks
The Number of Participants With Quit Attempts Lasting ≥ 24 Hours
Time frame: 6 weeks
Methods for Quitting Smoking
Time frame: 6 weeks

Results and safety

Results posted to the registry on 7 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smoking Cessation Intervention	13	4

Primary outcome: Feasibility of the Smoking Cessation Education Program

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Smoking Cessation Intervention n = 4
Value	4

Population analysed: 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.

Primary outcome: Participant Acceptability Rate of the Program

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale (1 to 7 scale)

Measure	Smoking Cessation Intervention n = 4
Value	5.9 (1.3)

Primary outcome: Participant Satisfaction With the Program

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale (1 to 5 scale)

Measure	Smoking Cessation Intervention n = 4
Value	4.5 (0.58)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smoking Cessation Intervention	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Smoking, Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Belinda Borrelli, PhD principal investigator

Henry M Goldman School of Dental Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Educational video and Text-message program in people with Smoking, Cessation, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Smoking Cessation Education Program (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04247061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.