Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03740490 |
| Other study ID # |
9860 |
| Secondary ID |
R01CA221819 |
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 26, 2019 |
| Est. completion date |
November 17, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 low socioeconomic status (SES) adults. 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. The Smart-T app uses a lapse risk estimator to identify moments of heightened
risk for lapse, and the algorithm tailors treatment messages in real-time based upon level of
imminent smoking lapse risk and currently present lapse triggers. This study will compare
smoking cessation rates for those randomized to the Smart-T app or the NCI QuitGuide app.
Description:
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 low SES adults. 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. The Smart-T app uses a lapse risk
estimator to identify moments of heightened risk for lapse, and the algorithm tailors
treatment messages in real-time based upon level of imminent smoking lapse risk and currently
present lapse triggers.
The study aims are to:
Determine the impact of treatment condition (i.e., Smart-T vs. QuitGuide app; n=225 per
group) on biochemically verified smoking abstinence. Hypothesis 1: Participants randomly
assigned to Smart-T will have significantly higher rates of biochemically-verified abstinence
than those assigned to QuitGuide at 26 weeks post-quit.
Determine the effect of Smart-T treatment messages on key lapse risk factors. Hypothesis 2:
Smoking urge, stress, and cigarette availability will decline more and cessation motivation
will increase more following tailored messages that target these lapse triggers in real-time
(Smart-T condition) compared with similar situations wherein no messages are provided
(QuitGuide condition).
EXPERIMENTAL DESIGN:
Participants (N=550) will be recruited through the TSET Health Promotion Research Center
(HPRC) Tobacco Treatment Research Program (TTRP) which is directed by Dr. Darla Kendzor
(Co-I). Participants will also be recruited through advertisements. Individuals seeking
smoking cessation services at the TTRP will be given a verbal description of the study during
their first visit, and those interested will be screened for study eligibility. Those who
respond to study advertisements will complete a brief RedCap screener online (i.e.,
OKSmokerstudy.com), and those who qualify for the study will contacted by study staff and
scheduled for a screening/baseline visit. Consistent with our previous research with low SES
populations, we have limited exclusion criteria so that the sample is as broad and
representative of the population as possible. Interested individuals will be included in the
study if they: 1) earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short
Form (REALM-SF)56 indicating > 6th grade English literacy level (required to complete EMAs;
at least 88% of all individuals screened for our EMA studies have met this inclusion
criterion), 2) are willing to quit smoking 7 days after the baseline assessment, 3) are ≥ 18
years of age, 4) have an expired CO level ≥ 7 ppm suggestive of current smoking for those who
attend in person baseline visits or substantiate smoking status (e.g., produce a pack of
cigarettes) during baseline assessments by sending picture of cigarettes to staff 5) are
currently smoking ≥ 5 cigarettes per day, 6) have no contraindications to using NRT, 7) agree
to complete EMAs and CO tests on a study provided or personal smartphone, 8) have household
income < 200% of the federal poverty guideline,57 and 9) agree to complete the 26 week
post-quit follow-up assessment over the phone and via EMA.
Eligible and interested individuals will be randomized to 1 of 2 groups: 1) Smart-T smoking
cessation intervention plus NRT, or 2) NCI QuitGuide smoking cessation intervention plus NRT.
Stratified randomization will be used to assign participants to groups based upon race, sex,
and cigarettes smoked per day. Participants will be followed for 27 weeks and will attend
either 1 in-person visit or complete phone-based baseline visits. Participants will be
prompted to complete daily EMAs and tests of smoking status using a portable, low-cost,
carbon monoxide monitor (Bedfont iCO Smokerlyzer) on 3 days each week. This data will be used
to address primary (i.e., biochemically verified 7-day point prevalence abstinence at 26
weeks post-quit) and secondary outcomes (e.g., 30-day point prevalence abstinence, number of
days to first lapse, longest period of smoking abstinence). Geographic location data will be
captured multiple times per day to link characteristics of the present environment (e.g.,
proximity to tobacco outlets) with cessation-related outcomes. We have already created
software that integrates the iCO sensor into our InsightTM mobile application platform.
Sub-Study Update: A sample(n=30) of American Indian/Alaska Native participants who have
completed the 6 month follow-up assessment will be asked to participate in another
qualitative interview designed to assess the perceived utility and cultural fit of the
Smart-T App.Information gathered from these qualitative interviews will be used to culturally
modify and then experimentally test a new, culturally tailored, version of the Smart-T app
for AI/AN smokers who want to quit smoking. In addition, this will serve as an incredibly
valuable training opportunity for an emerging Native American scientist to learn tobacco
cessation, mHealth, and qualitative methods research from an interdisciplinary team of
leading experts in the field.
PROPOSED PROCEDURE:
Individuals who provide informed consent and meet the study inclusion criteria will complete
the baseline assessment in TTRP clinic space (the TTRP is located in Research Parkway in a
building that is adjacent to the PI's office). Participants may alternatively complete the
baseline assessment via phone calls with study staff. Following the baseline assessment,
participants will be given instruction on how to complete phone-based EMAs and carbon
monoxide assessments. All participants, regardless of condition, will be compensated for
completing the baseline assessments, phone-based follow-up, and EMAs. In addition,
participants will complete expired breath carbon monoxide tests using the portable iCO device
3 days per week (weeks 1-27).
Baseline and follow-up measures will assess demographic and smoking characteristics, multiple
constructs that are known to be related to lapse (e.g., depression, stress, affect, social
support), and document intervention effects (See Table 3 and Appendix). We will also access
participant perceptions of each app feature. The Baseline process will take approximately
60-90 minutes to complete and data will be collected either on laptop/tablet computers using
Questionnaire Development System (QDS) software or remotely via RedCap surveys. QDS uses a
computer-administered self-interview format (i.e., ACASI), which reduces data entry errors
and the need to retain paper copies of raw data. Each item appears on the computer screen
while the program simultaneously reads the item (participants touch the screen to select
answers only after QDS reads each item). Participants wear headphones so that others do not
hear the survey items. Participants from our previous studies in similar populations,
including those with no computer experience, have reported few problems using the QDS
program. Staff will be available to help participants who may have difficulty. The RedCap
surveys have been designed to replicate the QDS version as closely as possible. The 26 week
post-quit follow-up assessment, which includes a longer EMA (i.e., 20-30 minutes) and a phone
call based interview (i.e., The Treatment Improvement Survey, 10-15 minutes) that will be
recorded for qualitative analysis.
Participants who own an Android smartphone (OS version 6.0 or higher) will be encouraged to
download and use the study app on their own phone. Those who do not own this type of
smartphone and those who do not have a data plan will be loaned a Samsung smartphone (or
equivalent) for 27 weeks so that they may complete EMAs. Participants will navigate through
the EMA program and enter data simply by touching the screen. The study app (i.e., Smart-T
app or EMA only app) includes a "Call Staff" function/button that automatically calls study
staff (e.g., if they have problems completing EMAs). The EMA app also includes a "Payment"
button which, when pressed, indicates the number of EMAs that have been prompted and
completed and the current level of compensation based upon the up-to-the-moment percentage of
EMAs completed. Smartphones will automatically collect data when on-demand features are
accessed for both the QuitGuide and Smart-T groups (e.g., number of times features are used).
Use of personal vs. study provided phones will be examined as a covariate in all analyses.
IMPORTANCE OF KNOWLEDGE REASONABLY EXPECTED TO RESULT FROM THE RESEARCH:
Although many smartphone based smoking cessation apps exist, none have been developed and
empirically validated via a randomized controlled trial in socioeconomically disadvantaged
populations of smokers who are seeking to quit smoking. This study is the next step in a line
of research that aims to develop and disseminate effective and automated treatments for
smoking cessation for this underserved and understudied population. Thus, the knowledge that
will be gained from this study is important. Furthermore, the Smart-T app will allow us to
reach a population that frequently lacks access to traditional intervention programs, due to
limited availability, income, and/or transportation, among other barriers. In addition, the
proposed smartphone app is highly versatile and may be easily modified for use in other
populations or communities. The risks to subjects are minimal, especially considering the
protections against risks that will be implemented for this study.
