Trial Outcomes & Findings for Smartband Mindfulness Study (NCT NCT03995225)

NCT ID: NCT03995225

Last Updated: 2024-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 155 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2024-02-15

Participant Flow

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).

Participant milestones

Measure	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
Overall Study STARTED	155
Overall Study Baseline Survey Completed	154
Overall Study Smartband Worn for at Least 1 Day	115
Overall Study Confirmed/Denied Smoking on Smartband	111
Overall Study Received Mindful Smoking Exercise Triggered by Smoking	114
Overall Study 21-day Survey Completed	112
Overall Study 28-day Survey Completed	101
Overall Study Primary Smoking Outcomes Reported at End of Treatment	96
Overall Study End of Treatment Survey Completed	95
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smartband Mindfulness Study

Baseline characteristics by cohort

Measure	Smokers n=155 Participants 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
Age, Customized	46.06 years STANDARD_DEVIATION 10.41 • n=5 Participants
Sex/Gender, Customized Female	83 Participants n=5 Participants
Sex/Gender, Customized Male	71 Participants n=5 Participants
Sex/Gender, Customized Female and Non-binary	1 Participants n=5 Participants
Race/Ethnicity, Customized Non-hispanic White	118 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic White	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Other or Multiracial	23 Participants n=5 Participants
Region of Enrollment United States	155 participants n=5 Participants
Education Some College	129 Participants n=5 Participants
Education GED/equivalent or high school or less education	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

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.

Outcome measures

Measure	Smokers n=111 Participants 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
Fidelity of Detecting Smoking Episodes Average percent of smoking events correctly detected	90.2 percentage of events Standard Deviation 17.5
Fidelity of Detecting Smoking Episodes Average percent of false alarms	9.8 percentage of events Standard Deviation 17.5

PRIMARY outcome

Timeframe: 39 days

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.

Outcome measures

Measure	Smokers n=114 Participants 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
Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking percent of mindful smoking exercises correctly triggered	95.6 percentage of events Standard Deviation 10.9
Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking percent of false alarms	9.8 percentage of events Standard Deviation 17.5

PRIMARY outcome

Timeframe: 30 days

Population: participants who completed at least one 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.

Outcome measures

Measure	Smokers n=84 Participants 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
Timeliness of Delivering RAIN Exercise Percent participants who rated timeliness as moderate, high or very high	83.3 percentage of participants
Timeliness of Delivering RAIN Exercise Percent participants who rated timeliness as very low or low	16.7 percentage of participants

PRIMARY outcome

Timeframe: 60 days

Percent of days spent wearing the smartband.

Outcome measures

Measure

Smokers n=115 Participants 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

Adherence to Wearing the Smartband

69.6 percentage of days Standard Deviation 30.5

PRIMARY outcome

Timeframe: 60 days

Percent of smoking notifications answered

Outcome measures

Measure

Smokers n=111 Participants 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

Adherence to Answering Smartband Notifications of Smoking Events

98.2 percentage notifications answered Standard Deviation 4

PRIMARY outcome

Timeframe: 60 days

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.

Outcome measures

Measure	Smokers n=115 Participants 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
Adherence to Answering Ecological Momentary Assessment Items When completed RAIN exercises	98.3 Percentage of ratings answered
Adherence to Answering Ecological Momentary Assessment Items When completed mindful smoking exercises	100 Percentage of ratings answered

PRIMARY outcome

Timeframe: 60 days

Population: Of the 115, 75 participants completed mindfulness exercises across treatment, 94 participants completed RAIN exercises across treatment

Percent of mindfulness exercises (RAIN, mindful smoking) completed

Outcome measures

Measure	Smokers n=115 Participants 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
Adherence to Completing Mindfulness Exercises mindful smoking exercises	40.3 percentage of exercises completed Standard Deviation 31
Adherence to Completing Mindfulness Exercises RAIN exercises	7.9 percentage of exercises completed Standard Deviation 13.9

PRIMARY outcome

Timeframe: 60 days

Population: Of the 115, 75 participants completed mindfulness exercises across treatment, 84 participants completed RAIN exercises across treatment

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.

Outcome measures

Measure	Smokers n=115 Participants 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
Acceptability of Intervention - Helpfulness of Mindfulness Exercises Completed at least one mindful smoking exercise and rated it as moderately or more helpful	74.7 percentage of participants
Acceptability of Intervention - Helpfulness of Mindfulness Exercises Completed at least one RAIN exercise and rated it as moderately or more helpful	76.2 percentage of participants

PRIMARY outcome

Timeframe: up to 60 days

Population: 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.

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.

Outcome measures

Measure	Smokers n=115 Participants 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
Acceptability of Intervention - User Experiences Survey Instructions for getting started with smartband were easy to follow at onboarding	110 percentage of participants
Acceptability of Intervention - User Experiences Survey Easy to wear smartband every day at day 21	101 percentage of participants
Acceptability of Intervention - User Experiences Survey Helpful to be notified of their smoking events at day 21	99 percentage of participants
Acceptability of Intervention - User Experiences Survey Liked being notified of their smoking events at day 21	104 percentage of participants
Acceptability of Intervention - User Experiences Survey Being notified of smoking events helped participants pay attention to their smoking at day 21	101 percentage of participants
Acceptability of Intervention - User Experiences Survey Mindful smoking exercise were helpful at day 28	80 percentage of participants
Acceptability of Intervention - User Experiences Survey Mindful smoking exercise helped them pay attention to their smoking at day 28	93 percentage of participants
Acceptability of Intervention - User Experiences Survey RAIN exercises were helpful at day 60	71 percentage of participants

SECONDARY outcome

Timeframe: 7 days

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)

Outcome measures

Measure	Smokers n=96 Participants 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
Number of Participants With Self-reported Abstinence From Smoking one week point prevalence	14 Participants
Number of Participants With Self-reported Abstinence From Smoking prolonged abstinence	29 Participants

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen A Garrison

Yale School of Medicine

Phone: 415-260-8618

Email: kathleen.garrison@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place