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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT010365-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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To determine treatment fidelity for a smartband/smartphone-based smoking monitoring, notification and brief mindfulness intervention.
This study will test the feasibility of using a smartband to detect and track smoking and deliver brief smoking cessation interventions by smartphone app in real time. Smokers will wear a smartband to detect and notify them of smoking for 21 days and obtain individual smoking profiles; detected smoking will then trigger a "mindful smoking" exercise for the next 7 days leading up to their quit date at 30 days; after which another mindfulness exercise ("RAIN": recognize, accept, investigate and note cravings rather than smoke) will be delivered prior to each predicted smoking episode according to their individual smoking profile for 30 days post-quit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers | Experimental | This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises by smartphone app. There is only one arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartband automatic smoking detection combined with brief mindfulness interventions | Behavioral | Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions and learn to work mindfully with cravings and triggers rather than smoke using RAIN prior to smoking episodes.This is a 3 step intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity of Detecting Smoking Episodes | Percent of smoking episodes detected and the rate of false alarms in the first 60 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes. | 60 days |
| Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms during which any detected and confirmed smoking event triggers the mindful smoking exercise. | 39 days |
| Timeliness of Delivering RAIN Exercise | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating timeliness of RAIN exercise as moderate or higher (via real-time ecological momentary assessment). Moderate or higher indicates a better (more timely) outcome. | 30 days |
| Adherence to Wearing the Smartband | Percent of days spent wearing the smartband. | 60 days |
| Adherence to Answering Smartband Notifications of Smoking Events | Percent of smoking notifications answered | 60 days |
| Adherence to Answering Ecological Momentary Assessment Items | Percentage of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered when participants completed mindfulness exercises. That is, did the participant complete the EMA when they completed the mindfulness exercise. Measured separately for percentage of EMA answered when participants completed RAIN exercises, and percentage of EMA answered when participants completed mindful smoking exercises. Reported is the percentage of EMA answered out of the number of completed mindfulness exercises, separately for RAIN and mindful smoking. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-reported Abstinence From Smoking | As a secondary aim we will also evaluate self-reported one-week point prevalence abstinence from smoking and prolonged abstinence from smoking (≤5 cigarettes since quit date) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen A Garrison, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34783663 | Derived | Horvath M, Grutman A, O'Malley SS, Gueorguieva R, Khan N, Brewer JA, Garrison KA. Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2021 Nov 16;10(11):e32521. doi: 10.2196/32521. |
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155 participants completed onboarding and were considered enrolled and provided demographics data. Of these, 154 participants completed the baseline survey. Of these, 115 participants wore the smartband for at least one day. A modified intent to treat sample was analyzed for outcomes, defined as participants who completed onboarding and wore the smartband for at least one day (N=115).
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| ID | Title | Description |
|---|---|---|
| FG000 | Smokers | This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises including RAIN by smartphone app. There is only one arm. Smartband automatic smoking detection combined with brief mindfulness interventions: Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Demographics were reported at enrollment, prior to the baseline survey, and therefore are reported for the enrolled sample (N=155).
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| ID | Title | Description |
|---|---|---|
| BG000 | Smokers | This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises including RAIN by smartphone app. There is only one arm. Smartband automatic smoking detection combined with brief mindfulness interventions: Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions |
| 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, Customized | 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 | Fidelity of Detecting Smoking Episodes | Percent of smoking episodes detected and the rate of false alarms in the first 60 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes. | Posted | Mean | Standard Deviation | percentage of events | 60 days |
|
up to 60 days
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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 | Smokers | This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises by smartphone app. There is only one arm. Smartband automatic smoking detection combined with brief mindfulness interventions: Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen A Garrison | Yale School of Medicine | 415-260-8618 | kathleen.garrison@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 | Jul 7, 2021 | Aug 23, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2021 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 60 days |
| Adherence to Completing Mindfulness Exercises | Percent of mindfulness exercises (RAIN, mindful smoking) completed | 60 days |
| Acceptability of Intervention - Helpfulness of Mindfulness Exercises | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating helpfulness as moderate or higher of participants that completed at least one mindful smoking or RAIN exercise. | 60 days |
| Acceptability of Intervention - User Experiences Survey | Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) by theme- One survey with feasibility determined by 75% of participants rating the question as moderate or higher. Below are percentage of participants with ratings of moderate or higher for each question. | up to 60 days |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Primary | Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms during which any detected and confirmed smoking event triggers the mindful smoking exercise. | Posted | Mean | Standard Deviation | percentage of events | 39 days |
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| Primary | Timeliness of Delivering RAIN Exercise | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating timeliness of RAIN exercise as moderate or higher (via real-time ecological momentary assessment). Moderate or higher indicates a better (more timely) outcome. | participants who completed at least one RAIN exercise | Posted | Number | percentage of participants | 30 days |
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| Primary | Adherence to Wearing the Smartband | Percent of days spent wearing the smartband. | Posted | Mean | Standard Deviation | percentage of days | 60 days |
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| Primary | Adherence to Answering Smartband Notifications of Smoking Events | Percent of smoking notifications answered | Posted | Mean | Standard Deviation | percentage notifications answered | 60 days |
|
|
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| Primary | Adherence to Answering Ecological Momentary Assessment Items | Percentage of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered when participants completed mindfulness exercises. That is, did the participant complete the EMA when they completed the mindfulness exercise. Measured separately for percentage of EMA answered when participants completed RAIN exercises, and percentage of EMA answered when participants completed mindful smoking exercises. Reported is the percentage of EMA answered out of the number of completed mindfulness exercises, separately for RAIN and mindful smoking. | Posted | Number | Percentage of ratings answered | 60 days |
|
|
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| Primary | Adherence to Completing Mindfulness Exercises | Percent of mindfulness exercises (RAIN, mindful smoking) completed | Of the 115, 75 participants completed mindfulness exercises across treatment, 94 participants completed RAIN exercises across treatment | Posted | Mean | Standard Deviation | percentage of exercises completed | 60 days |
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| Primary | Acceptability of Intervention - Helpfulness of Mindfulness Exercises | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating helpfulness as moderate or higher of participants that completed at least one mindful smoking or RAIN exercise. | Of the 115, 75 participants completed mindfulness exercises across treatment, 84 participants completed RAIN exercises across treatment | Posted | Number | percentage of participants | 60 days |
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| Primary | Acceptability of Intervention - User Experiences Survey | Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) by theme- One survey with feasibility determined by 75% of participants rating the question as moderate or higher. Below are percentage of participants with ratings of moderate or higher for each question. | N based on number of participants that answered the question at each milestone out of the 115 that wore the smartband for at least one day. | Posted | Number | percentage of participants | up to 60 days |
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| Secondary | Number of Participants With Self-reported Abstinence From Smoking | As a secondary aim we will also evaluate self-reported one-week point prevalence abstinence from smoking and prolonged abstinence from smoking (≤5 cigarettes since quit date) | Posted | Count of Participants | Participants | 7 days |
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| 0 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
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| Helpful to be notified of their smoking events at day 21 |
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| Liked being notified of their smoking events at day 21 |
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| Being notified of smoking events helped participants pay attention to their smoking at day 21 |
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| Mindful smoking exercise were helpful at day 28 |
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| Mindful smoking exercise helped them pay attention to their smoking at day 28 |
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| RAIN exercises were helpful at day 60 |
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