NCT05233228 Mobile Health Technology for Personalized Tobacco Cessation Support in Laos
| NCT ID | NCT05233228 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Oklahoma |
| Condition | Cigarette Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2026-08-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
In Lao People's Democratic Republic (Lao PDR), 51% of adult men and 7% of adult women smoke tobacco. The development and evaluation of sustainable tobacco cessation interventions suitable for widespread adoption in nations such as Lao PDR are pressing public health needs. To address this need, the investigators propose a project that adapts a theoretically and empirically based mobile health (mHealth) technology to help people quit smoking cigarettes in Lao PDR. This mHealth approach includes a fully automated, interactive, personalized, smartphone-delivered intervention for behavioral treatment, delivered through our Insight™ platform. This proposed project for Lao PDR includes 2 main phases. In the R21 Phase, the investigators will use formative research methods to adapt our intervention content to the sociocultural context, language, and communication styles of Laotians. In the subsequent R33 Phase, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of our mHealth intervention and technology. Adult smokers of both sexes will be recruited through 2 large hospitals: Setthathirath Hospital in Vientiane and Champasak Hospital in Champasak Province. Participants (n=500) will be randomized to 1 of 2 treatment groups: Standard Care (SC; n=250) or Automated Treatment (AT; n=250). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of NRT (transdermal patches). AT consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos. The primary health outcome of the trial is biochemically confirmed self-reported 7-day point prevalence abstinence 12 months post study enrollment. The project also aims to advance mHealth research capacity in Lao PDR and sustain the US-Lao PDR research network. The project has the potential to transform healthcare services for tobacco cessation treatment throughout the country and, ultimately, to reduce tobacco-induced morbidity and mortality significantly.
Eligibility Criteria
Inclusion Criteria: (pilot RCT in the R21 Phase and main RCT in the R33 Phase): 1. aged ≥18 years 2. self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day) 3. willing to set a quit date within 2 weeks of study enrollment 4. able to provide written informed consent to participate 5. able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form). Exclusion Criteria: (pilot RCT in the R21 Phase and main RCT in the R33 Phase) 1. history of a medical condition that precludes use of NRT 2. ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician 3. enrollment in another cessation program or current use of other cessation medications.