Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

R21 Phase: Adaption of the AT intervention contentIn stage 1, formative research, including literature searches, quantitative results, andqualitative methods (e.g., key informant interviews) are often conducted to determine howwell an original intervention will fit the needs and preferences of the targetpopulation. The investigators will conduct in‐depth interviews with 30 healthcareproviders at participating hospitals to learn more about how they typically motivatepatients to quit smoking and stay abstinent. Inclusion criteria for all healthcareproviders in the R21 Phase include 1) age ΓëÑ18 years; and 2) the ability to providewritten informed consent to participate. They can develop intervention messages if theywish or pinpoint the sources of treatment content that they use. The investigators willuse purposive sampling to select 15 providers from each hospital, 15 of each sex, andensure the sample is diverse with regard to age and specialty. Also, the investigatorswill conduct 8 focus group discussions with 40‐60 patients who smoke (5‐8 persons/group,4 groups/hospital) to identify additional factors that motivate patients to quit smokingand stay abstinent, barriers to quitting, and strategies to overcome these barriers.Inclusion criteria for all patients in the R21 Phase include 1) age ΓëÑ18 years; 2)self‐reported current combustible cigarette smoking (smoked ΓëÑ100 cigarettes in lifetimeand currently smoke ΓëÑ1 cigarette/day); 3) planning to quit in the next 6 months or havingactually made a quit attempt; and 4) the ability to provide written informed consent toparticipate. The investigators will use purposive sampling to select a diverse samplewith regard to age, residence (urban vs. rural), disease type, and cessation phase, perthe Phase‐Based Model (PBM; see Conceptual Framework). The investigators will conductseparate group discussions for men and women (2 groups for each sex at each hospital).For all qualitative components in the R21 Phase, the investigators will use open‐endedquestions in all interviews/discussions. All interviews/discussions will be recordedusing a digital voice‐recording app on an encrypted smartphone and will be transcribedverbatim. Qualitative data will be analyzed using thematic content analysis with the aidof the R‐based Qualitative Data Analysis software package. Themes will be based on thepurpose of each component and on theoretical constructs of the PBM.In stage 2, the investigators will integrate information gathered in the first stage tomodify the original intervention. Also at this stage, the investigators will translateall English intervention materials and assessments that will be used in the R33 Phase toLao, mirroring the WHO's recommended methodology. First, a health scientist, whose nativelanguage is Lao, will lead the forward translation process, focusing on conceptual (vs.literal) meaning and comprehensible language for the broadest audience. Second, a moresenior bilingual health expert will review the translation, discuss disagreements withthe forward translator, edit, and finalize the forward translation. Third, 2 otherbilingual health professionals will independently rate the quality of the translation on5 dimensions: conceptual equivalence, clarity in meaning, comprehensibility, use ofcommon simple language, and cultural appropriateness. Any discrepancies will be discussedto reach consensus on translation or editing. Fourth, the investigators will conduct 6panel discussions (1 with female smokers, 1 with male smokers, and 1 with mixed‐sexhealthcare professionals at each participating hospital; 5‐7 panelists per group). Thisstep aims to evaluate material comprehensibility as well as linguistic and culturalappropriateness for the target populations, particularly to identify linguisticdifferences by regions (north vs. south) in Lao PDR and to find and use common words.Fifth, 2 other bilingual health professionals will independently backward translate thematerials into English. Finally, the PI and site‐PI will independently review and ratethe backward‐translations for conceptual equivalence with the original English versions.In stage 3, the investigators will load the intervention content onto the InsightΓäóplatform and assessments into REDCap and will preliminarily test them (on smartphones/tablets) with 20 patients who smoke (10 male, 10 female). Additionally, the investigatorswill systematically document continuous feedback from local investigators and staffmembers who implement stages 2 and 3 for adaption refinement. In stage 4, theinvestigators will refine the intervention based on the results and feedback from stage3. Critical changes at this stage (e.g., major deviations from the original intervention)will only be made in consultation with the leadership team.Stage 5 will be a 3‐month pilot efficacy trial with 50 patients. Activities at this stagewill mirror the full efficacy trial in the R33 Phase, except that only 50 patients willbe recruited and treatment will last 3 months. In addition to the efficacy outcomes, theinvestigators will collect data for further adaption and refinement.R33 Phase: Conduct a RCT to evaluate the efficacy of AT:Sites and participant recruitment: Participants (n=500) will be recruited from thepatient populations at Setthathirath Hospital (SH) in Vientiane and Champasak Hospital(CH) in Champasak Province. All non‐emergency patients coming to SH and CH first go to areception desk to receive a queue number and a basic medical form. A flyer thatintroduces this study will be attached to the basic medical form. Additionally, theinvestigators will proactively recruit patients at the Respiratory Disease ScreeningUnits (RDSU) and departments/clinics specializing in women's health (e.g., Gynecology,and Breast and Gynecologic Cancer). Due to the national organization and implementationof NCLE's disease control programs, all patients visiting SH or CH with respiratorysymptoms are first examined at the RDSU for type of disease, severity, and whether thedisease is included in a national disease control program (e.g., tuberculosis or severeacute respiratory syndrome). Patients are then referred to appropriatedepartments/clinics or disease control units.Baseline assessment. Enrolled participants will complete a 45‐minute tablet‐deliveredbaseline audio computer‐assisted self‐interview, managed and delivered by REDCap.Research staff will assist participants complete the assessment if needed. Participantswill be assigned to a treatment group using a form of adaptive randomization calledminimization, this ensures better group balance regarding participant characteristics anddoes not impose limitations such as empty or near‐empty strata. Randomization variablesinclude biological sex, nicotine dependence, and reading level. All participants willcomplete a brief training session on smartphone use and the InsightΓäó app. Smartphoneswill be loaned to participants who need them.Treatment groups. Standard Care (SC): Participants randomized to SC will receive briefadvice to quit smoking delivered by research staff, NTCC's self‐help materials (developedbased on the WHO's "A guide for tobacco users to quit"), and a 2‐week supply of NRT(patches). SC participants will be asked to complete weekly 4‐item smartphone‐deliveredassessments about their diet (see explanation in Measures) for a 6‐month period.Automated Treatment (AT): Participants in the AT group will receive the SC components(except the dietary assessments) plus proactive personalized messages/images/videos forsmoking cessation. The AT content is adapted from the team's previous efforts (seePreliminary Studies), is informed by the R21 phase outcomes, and is designed to tap thetheoretical mechanisms described in the PBM. That is, AT content is designed to increasemotivation, self‐efficacy, and use of coping skills, while reducing nicotine withdrawalsymptoms and stress. AT will begin immediately after enrollment and continue for a26‐week period (about 2 messages/images/videos per day). The AT approach allows forseveral levels of personalization for each participant. First, at baseline, participantswill be asked several questions about past quit attempts, preferred coping skills, andthe presence or fear of specific health conditions. Treatment content tailored to theseresponses will be automatically delivered throughout the treatment period. Second, therewill be different bins of treatment content for different cessation phases to ensure thatAT targets critical mechanisms of each participant's PBM phase, which may dynamicallychange during treatment. Third, participants will be asked to complete brief (4 items)smartphone‐delivered assessments during each week of the AT course. These questions willvary depending on each participant's phase (e.g., current level of intrinsic motivationfor preparation or maintenance phases or smoking status in the past week andself‐efficacy level for all phases). Treatment content (e.g., types and frequencies ofmessages) for the following week will be based on responses to these weekly assessmentsand participant phases (e.g., level of self‐efficacy or past‐week smoking status). Ourteam's previous work with disadvantaged populations has observed high adherence (76%)with weekly smartphone assessments across a 6‐month timeframe.Participants will be followed up for 12 months but AT and weekly assessments will stop atmonth 6.