Over 470,000 tobacco users have been served by the Oklahoma Tobacco Helpline (OTH). The
OTH reaches a substantial number of smokers each year, but follow-up rates are
notoriously low and many smokers may prefer smartphone-based smoking cessation
interventions rather than web- or phone-based OTH programming (e.g., counseling). Highly
flexible and low burden technology-based treatment approaches may overcome barriers that
have limited the use and effectiveness of traditional smoking cessation treatments among
underserved adult smokers (e.g., racial/ethnic minorities, rural residence, low
socioeconomic status). This study is a randomized controlled trial that will evaluate the
feasibility and initial efficacy of an innovative, evidence-based smoking cessation app
tailored for smokers that contact the OTH for services. A total of 500 treatment-seeking
men and women will be randomly assigned to receive either Standard Helpline Care plus
brief (30 second) daily check-ins and weekly smartphone-based surveys through the Insight
app (SC) or SC plus the OKquit smoking cessation app (OKq). All participants will receive
standard Helpline services (e.g., nicotine replacement therapy), but only the OKq group
will receive on-demand content and tailored messages through the app. All participants
will be followed for 27 weeks after they are randomized to an intervention group and
complete smartphone-based survey assessments. Participants that report smoking abstinence
during the 26-week EMA will be sent a low-cost carbon monoxide monitor to verify smoking
status.
PROPOSED PROCEDURE:
Individuals who call the OTH will be asked if they own a smartphone (>85% of US adults
currently own a smartphone). Those that own a smartphone that is compatible with our
Insight™ mHealth Platform will be asked if they are interested in participating in this
study. Interested individuals will be sent a link to the REDCap study screener by phone,
email, or text (via OTH provider and/or this research team) so that they can complete the
study screener. Those that qualify for the study will be called by Dr. Businelle's
research team to complete informed consent, finalize enrollment, and be randomized into a
study group. All participants will use a version of the Insight™ app (i.e., SC assessment
only app or OKquit app which contains assessments and intervention content) to complete a
brief Baseline survey. Upon completion of the Baseline survey, participants will be
randomized to an intervention group and use the app to set a quit date within the next 21
days. Note: A minimization technique will be used to ensure that groups are balanced by
race (white vs. non-white), biological sex (male vs. female), and cigarettes smoked per
day (<20 vs. 20 or more). During the randomization call, participants will be instructed
on how to complete phone-based EMAs. Participants who do not complete the baseline
assessment and randomization call will be removed from the study.
After randomization, the app will prompt a brief daily check-in (e.g., 4 questions) and
weekly assessments (~30 questions; both groups). During the morning check-in assessment,
all participants will elect to complete 0-5 additional brief check-ins (i.e., 2
questions) that day. Responses to these check-ins are used to collect information about
relapse risk and automatically TAILOR OKq intervention messages to the participant's
current needs in real-time. Consistent with the Phoenix pilot, the weekly EMA will be
prompted by the smartphone app on Saturdays. The phone will ring and vibrate to cue these
EMAs. This EMA will ask questions about current and past week thoughts, feelings, and
behaviors. All participants (both groups) that report they did not smoke in the past 7
days during the week 26 weekly survey will be mailed a low-cost carbon monoxide monitor
that has been paired with the Insight™ smartphone application to verify abstinence. All
contact with research staff will occur remotely - there will be no required in person
visits for this study. Participants will be compensated $20 for completing the study
baseline, $5 for completing each weekly study survey for 27 weeks, and $50 for completing
the app-based end of study follow-up assessment. Thus, total compensation will be up to
$205 plus an additional $20 for those who complete the end of study biochemical
verification of smoking abstinence (only those that report abstinence at the end of the
study will be asked to verify smoking abstinence).
IMPORTANCE OF KNOWLEDGE REASONABLY EXPECTED TO RESULT FROM THE RESEARCH:
Smoking is becoming increasingly concentrated among individuals with the lowest levels of
income, education, and occupational status. In fact, smoking rates in the United States
among people living below the poverty line is nearly twice as high as those above the
poverty threshold. Highly flexible and low burden technology-based treatment approaches
may overcome many of the barriers that have limited the use and effectiveness of
traditional smoking cessation treatments among adults with low socioeconomic status
(SES). Ecological momentary assessment (EMA), in which mobile devices are used to capture
moment-to-moment experiences, allows for the measurement of phenomena in real-time within
natural settings. Smartphone-based smoking cessation apps could offer easily accessible,
highly tailored, and intensive interventions at a fraction of the cost of traditional
smoking cessation counseling.