- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247061
Usability Study of a Smoking Cessation Intervention During a Dental Cleaning
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02118
- Goldman School of Dental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
A one-month text message program to motivate and facilitate contact with smoking cessation resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 weeks
|
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.
|
6 weeks
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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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attitudes About Smoking
Time Frame: 6 weeks
|
The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking.
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6 weeks
|
Change in Number of Cigarettes Smoked Per Day
Time Frame: Baseline, 6 weeks
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An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily
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Baseline, 6 weeks
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The Number of Participants With Quit Attempts Lasting ≥ 24 Hours
Time Frame: 6 weeks
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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
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6 weeks
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Methods for Quitting Smoking
Time Frame: 6 weeks
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An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking
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6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Belinda Borrelli, PhD, Henry M Goldman School of Dental Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-39053
- 1UG3DE028866 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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