Smoking Cessation, Smoking (Tobacco) Addiction
Conditions
Keywords
cigarette smoking, chatbot
Brief summary
The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness. In this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be
Interventions
OTHERchatbot
a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers
OTHERno chatbot
no chatbot is provided
Sponsors
University of Minnesota
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Identify as Black or African American * Be at least 21 years of age * Meet a minimum smoking amount * Be willing to make a quit attempt in the next 30 days * Have a smartphone capable of downloading and running the study app * Be able to upload data from the app * Agree to receive text message reminders about study activities * Be a native English speaker * Reside in Minnesota.
Exclusion criteria
* Medicinal nicotine use would require careful monitoring by a healthcare professional * Medical condition or medication used likely to significantly interfere with study outcomes or to be significantly affected by changes in smoking behavior * Are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of trial procedures | 1 day | The proportion of enrolled participants who download the study app |
| Feasibility of study procedures | 2 weeks | The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit |
| Health Information Technology Usability Evaluation Scale (Health-ITUES) | 2 weeks | This scale will be used to access the acceptability of study app. The scale consists of 20 questions scored from 1 to 5 with higher values indicating more positive response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of daily interactions with the study app | 2 weeks | — |
| The average number of cigarettes smoked per day | 2 weeks | — |
| Average number of nicotine lozenges used | 2 weeks | — |
| The proportion of participants who complete the week 8 post-quit visit | 8 weeks | — |
| The proportion of participants not smoking for the 7 day period before the week 2 visit | 2 weeks | — |
| The proportion of participants not smoking for the 7 day period before the week 8 visits | 8 weeks | — |
| The proportion of participants not smoking at all between the quit date and the week 2 visit | 2 weeks | — |
| The proportion of participants not smoking at all between the quit date and the week 8 visit | 8 weeks | — |
| Motivation to quit smoking | 2 weeks | Using a 1 - 10 scale on the contemplation to quit ladder (1 - no interest in quitting; 10 - will never smoke again) |
| Brief Questionnaire of Smoking Urges (QSU-Brief) | 2 weeks | Questionnaire assessing craving severity. Range for total score is 10 - 70 with higher score indicating greater craving |
| The Minnesota Nicotine Withdrawal Scale (MNWS) | 2 weeks | Questionnaire assessing withdrawal symptom severity. Range for total score is 0 - 36 with higher score indicating greater withdrawal symptoms |
Countries
United States
Contacts
CONTACTSheena Study Coordinator
PRINCIPAL_INVESTIGATORMichael Kotlyar
University of Minnesota
Outcome results
None listed