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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DE028866 | U.S. NIH Grant/Contract | View source |
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Due to COVID-19 policies this usability pilot study was stopped after enrolling 4 participants.
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Smoking Cessation Education Program | The number of participants who watched the video and used the text messaging for a month. | 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. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes About Smoking | The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking. | 6 weeks |
| Change in Number of Cigarettes Smoked Per Day |
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Inclusion Criteria:
Exclusion Criteria:
-Planning to move out of the Greater Boston area within the next two months
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| Name | Affiliation | Role |
|---|---|---|
| Belinda Borrelli, PhD | Henry M Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goldman School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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16 subjects were enrolled (provided informed consent to participate)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Smoking Cessation Education Program | The number of participants who watched the video and used the text messaging for a month. | 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. | Posted | Count of Participants | Participants | 6 weeks |
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6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Center for Behavioral Science Research | Boston University | 6173583358 | belindab@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2020 | Mar 17, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2020 | Mar 9, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2020 | Jan 27, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Text-message program | Other | A one-month text message program to motivate and facilitate contact with smoking cessation resources. |
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An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily
| 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 | 6 weeks |
| Methods for Quitting Smoking | An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking | 6 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale (1 to 7 scale) | 6 weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale (1 to 5 scale) | 6 weeks |
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| Secondary | Attitudes About Smoking | The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Change in Number of Cigarettes Smoked Per Day | An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily | 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. | Posted | Baseline, 6 weeks |
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| 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 | 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. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Methods for Quitting Smoking | An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking | 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) | Posted | Count of Participants | Participants | 6 weeks |
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| 0 |
| 4 |
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| 4 |
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| 4 |
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| Title | Measurements |
|---|---|
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| Gradually cutting back cigarettes |
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| Nicotine replacement patch |
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| Quit smoking mobile apps |
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| Quit smoking text message program (other than VR study text message) |
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| Quit smoking online program |
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| Watched a video on how to stop smoking (other than video watched at dental visit) |
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