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| Name | Class |
|---|---|
| Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research | OTHER |
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This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.
The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-Time Smoking Intervention | Experimental | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. |
|
| Standard Treatment | Active Comparator | Adult smokers will receive standard outpatient tobacco treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time Smoking Intervention | Behavioral | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cigarettes | Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| % Days Abstinent From Cigarettes | Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krysten Bold, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real-Time Smoking Intervention | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. |
| FG001 | Standard Treatment | Adult smokers will receive standard outpatient tobacco treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Real-Time Smoking Intervention | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Cigarettes | Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline and Week 8 |
|
8 week treatment period
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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 | Real-Time Smoking Intervention | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krysten Bold, PhD | Yale School of Medicine | 2039747603 | krysten.bold@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2020 | Apr 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
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| Standard Treatment | Behavioral | Adult smokers will receive standard outpatient tobacco treatment. |
|
| BG001 | Standard Treatment | Adult smokers will receive standard outpatient tobacco treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Self-report data on sex was missing for N=4 participants, N=2 in each condition. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
|
| Secondary | % Days Abstinent From Cigarettes | Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes. | Posted | Mean | Standard Deviation | percentage of days | Week 8 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Standard Treatment | Adult smokers will receive standard outpatient tobacco treatment. Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|