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Usability Study of a Smoking Cessation Intervention During a Dental Cleaning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247061
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : January 29, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Boston University

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.


Condition or disease Intervention/treatment Phase
Smoking, Cessation Other: Educational video Other: Text-message program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.
Other: 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

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




Primary Outcome Measures :
  1. 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 will be divided by the total number of participants enrolled to determine the feasibility of the intervention.

  2. Participant acceptability rate of the program [ Time Frame: 6 weeks ]
    The number of participants who liked the video and the text messaging for a month will be divided by the total number of participants enrolled to calculate the acceptability rate.

  3. Participant satisfaction with the program [ Time Frame: 6 weeks ]
    An investigator-developed survey will ask participants questions about how satisfied they were with the smoking cessation program


Secondary Outcome Measures :
  1. Change in attitudes about smoking [ Time Frame: Baseline, 6 weeks ]
    An investigator-developed survey will ask participants questions about their attitudes toward smoking

  2. Change in number of cigarettes smoked per day [ Time Frame: Baseline, 6 weeks ]
    An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily

  3. Change in the number of quit attempts lasting ≥ 24 hours [ Time Frame: Baseline, 6 weeks ]
    An investigator-developed survey will ask participants questions about the number of quit attempts lasting ≥ 24 hours

  4. Methods for quitting smoking [ Time Frame: 6 weeks ]
    An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247061


Locations
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United States, Massachusetts
Goldman School of Dental Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Belinda Borrelli, PhD Henry M Goldman School of Dental Medicine
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04247061    
Other Study ID Numbers: H-39053
1UG3DE028866 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Dental cleaning
Video
Text messages