PASCAL Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
chatbot
Other interventiona chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers
no chatbot
Other interventionno chatbot is provided
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: chatbot assisted smoking trigger managementExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of trial procedures
The proportion of enrolled participants who download the study app
Time frame
1 day2
Feasibility of study procedures
The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit
Time frame
2 weeks3
Health Information Technology Usability Evaluation Scale (Health-ITUES)
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
Time frame
2 weeksSecondary outcomes
1
Average number of daily interactions with the study app
Time frame
2 weeks2
The average number of cigarettes smoked per day
Time frame
2 weeks3
Average number of nicotine lozenges used
Time frame
2 weeks4
The proportion of participants who complete the week 8 post-quit visit
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov