Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05539209 |
| Other study ID # |
14792 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 13, 2022 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
February 2024 |
| Source |
University of Oklahoma |
| Contact |
Michael S Businelle, PhD |
| Phone |
405-271-8001 |
| Email |
michael-businelle[@]ouhsc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
