Clinical trial NCT03740490: Smartphone Based Smoking Cessation Intervention
Official title: Smartphone Based Smoking Cessation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Smartphone Based Smoking Cessation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-14
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating \> 6th grade English literacy level
2. are willing to quit smoking 7 days after the baseline visit
3. are ≥ 18 years of age
4. have an expired CO level ≥ 8 ppm suggestive of current smoking
5. are currently smoking ≥ 5 cigarettes per day
6. have no contraindications to using nicotine replacement therapy (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
9. agree to complete the 26 week post-quit follow-up assessment over the phone and via EMA

Exclusion Criteria:

1. cannot read, speak, and understand English
2. are \< 18 years of age

Primary outcomes:
measure: Biochemically-Verified Smoking Cessation
timeFrame: 27 Weeks
Secondary outcomes:
measure: Change in smoking urge
timeFrame: 27 weeks
measure: Change in stress
timeFrame: 27 weeks
measure: Change in cigarette availability
timeFrame: 27 weeks
measure: Change in cessation motivation
timeFrame: 27 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center - HPRC
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Michael S Businelle, PhD
role: PRINCIPAL_INVESTIGATOR
References: